On October 3, 2018, the week of our fifth anniversary, we processed and shipped our 40,000th FMT preparation. In partnership with stool donors and healthcare professionals across the country, these treatments have traveled to a network of more than 1,100 hospitals and clinics that have reshaped medical care for patients with recurrent C. difficile.
The pilot, open-label study is funded by Gates Foundation, Child Relief International and the Thrasher Research Fund.
SOMERVILLE, Mass. – This month, OpenBiome celebrated two notable milestones in its effort to expand safe access to fecal microbiota transplantation (FMT):
- OpenBiome partnered with its 1,000th clinical provider.
- OpenBiome shipped out its 30,000th treatment.
OpenBiome is pleased to announce a collaboration with the American Gastroenterological Association (AGA) on the Fecal Microbiota Transplantation (FMT) National Registry, planned to be the largest observational FMT study in history.
SOMERVILLE, Mass. – The Board of Directors of OpenBiome announced today that with unanimous and enthusiastic support, they have named Carolyn Edelstein, MPA, as OpenBiome’s new Executive Director, effective today.
Edelstein will succeed James Burgess, who will remain on the Board of Directors. He will be transitioning to VP of Innovation at Finch Therapeutics after serving as founding Executive Director since OpenBiome’s launch in 2012.
“Carolyn has been deeply involved in every aspect of our growth since our start,” said Burgess, “Her energy, skill, and wisdom have shaped everything from our patient-centered approach, to our groundbreaking research collaborations, to our partnership with the FDA. I couldn’t be more excited to see where she leads OpenBiome next.”
As one of the founding members of OpenBiome, Edelstein has been guiding the development, mission, and values of the organization since its inception. Her efforts as Director of Outreach and Public Affairs shaped OpenBiome’s public presence and brought awareness of and access to life-saving FMT to patients, doctors, and researchers around the world.
“We are incredibly fortunate to have Carolyn at the helm of OpenBiome as we enter our sixth year,” said Jim Burnham, Chairman of the Board of Directors, “Her dedication to our mission and her inspiring vision for the future will keep OpenBiome at the forefront of patient treatment and cutting-edge research into the microbiome.
Edelstein’s work on FMT access and regulation has appeared in Nature Biotechnology, the Journal of Law and the Biosciences, and Clinical Research and Regulatory Affairs. She has overseen OpenBiome’s coverage in major national and international media outlets, including The New York Times, CNN, NPR, BBC, AP and many others.
Previously, she worked at the U.S. Agency for International Development, where she helped launch the Global Innovation Fund, a $200 million institution backed by foreign aid agencies from the U.S., U.K., Canada, Australia, Sweden, and South Africa to test and support low-cost, high-impact interventions to improve global health and prosperity. She holds an MPA and a BA from Princeton University's Woodrow Wilson School of Public and International Affairs, where she was awarded the Scholars in the Nation's Service Initiative (SINSI) Fellowship, a four-year program to support outstanding individuals to launch careers in public service.
OpenBiome is the first public stool bank, founded to expand safe access to fecal transplantation for patients with recurrent C. difficile infection and to catalyze research on the microbiome’s role in human health. OpenBiome provides clinicians with rigorously screened, ready-to-use stool preparations and supports researchers with a suite of tools to discover how gut bacteria might treat diseases beyond C. difficile. Since 2013, OpenBiome has partnered with over 900 healthcare institutions across all 50 states and 7 countries to deliver nearly 30,000 treatments for recurrent C. difficile. Its research portfolio includes 49% of all U.S. trials exploring the use of fecal transplants to treat disease.
The nonprofit stool bank shared data from a 1,413 patient cohort of fecal transplant recipients and research from 14 abstracts at Digestive Disease Week.
SOMERVILLE, Mass — OpenBiome, a public stool bank, presented new research on fecal microbiota transplantation (FMT) at the 2017 Digestive Disease Week (DDW) meeting in Chicago. Among the five abstracts accepted were studies on whether specific bacteria in FMT drive clinical cure of recurrent Clostridium difficile infection (CDI), the effects of stool donor diet on clinical outcomes, stool processing time and FMT quality, and pediatric access to FMT. OpenBiome also coauthored an additional 9 abstracts presented at the meeting.
One of OpenBiome’s studies won a DDW award for an outstanding poster. Shrish Budree, MD, Clinical Research Fellow at OpenBiome, and Pratik Panchal, MD, MPH, won recognition for “Pediatric Access to Fecal Microbiota Transplantation for Recurrent Clostridium difficile Infection in the United States and the Impact of Stool Banks: A Geospatial Analysis.” According to this study by Budree et al., pediatric Clostridium difficile patients have much less access to FMT than the adult population. Budree and his colleagues found that 72.4% of the U.S. population lives within a 4-hour drive of a pediatric FMT provider, and just 49.4% of the population lives within a 2- hour drive of a pediatric FMT provider. By contrast, previous research has shown that 99.7% of adult patients live within a 4-hour drive of an FMT facility, and 96.7% have an FMT provider within a 2-hour drive.
Dr. Budree also presented findings on several factors that theoretically could affect donor stool FMT efficacy for recurrent CDI: donor metabolomics, diet, stool consistency, and laboratory processing time. Budree and his team collected complete clinical, microbial and metabolomics data for fecal material from 59 donors whose material was used across 1,413 patients with CDI (mean clinical cure rate 84.9%).
Budree et al.’s study of stool pathology and donor nutrition (long-term intake of fiber, fat, calories, and carbohydrates) found that these factors did not significantly change patient outcomes. Another Budree et al. study showed that for stool with a Bristol Stool Scale score of 3-5, donor stool consistency is not associated with clinical cure rates among patients treated with FMT for CDI. Budree et al. found no statistically significant factors driving differences in observed patient outcomes in these studies. These findings suggest that other variables such as patient-specific factors may be causing differences in cure rates for FMT in recurrent CDI.
A final abstract by Budree et al. showed no difference in microbial abundance in stool processed within 30 min or 180 minutes after passage, suggesting that longer stool processing times do not promote pathological microbial bloom, and would not affect FMT effectiveness for CDI.
DDW was held May 5-7 in Chicago, IL. More information about OpenBiome, including its mission, patient stories, and Quality & Safety Assurance program, is available at www.openbiome.org.
Full list of OpenBiome and OpenBiome affiliate posters, DDW 2017
Do specific bacteria drive clinical cure in fecal microbiota transplantation for Clostridium difficile infection? Clinical, microbial and metabolomic characterization of universal FMT donors (Budree et al.)[view]
The association of donor stool consistency by Bristol stool scale on microbial profile and clinical outcomes of fecal microbiota transplantation in Clostridium difficile infection (Budree et al.)[view]
The association of stool donor diet on microbial profile and clinical outcomes of fecal microbiota transplantation in clostridium difficile infection (Budree et al.) [view]
Donor stool processing time: the effect on the intestinal microbiome and clinical outcomes of fecal microbiota transplantation in Clostridium difficile Infection Budree et al.)[view]
Pediatric access to fecal microbiota transplantation for recurrent Clostridium difficile Infection in the United States and the impact of stool banks: a geospatial analysis (Panchal et al.)[view]
Fecal microbiota transplant using a precision medicine approach is safe, associated with lower hospitalization risk and improved cognitive function in recurrent hepatic encephalopathy. (Bajaj et al.) [view]
Prevalence of early antibiotic use post-fecal microbiota transplantation and corresponding risk of FMT failure. (Allegretti et al.)[view]
Does Rifaximin prior to fecal microbiota transplantation improve clinical outcomes compared to microbiome restoration alone in ulcerative colitis? A cohort study evaluating the impact of non-absorbable antibiotic pretreatment. (El-Nachef et al.) [view]
Fecal microbiota transplantation is safe and effective in chronic pouchitis patients (El-Nachef et al.) [view]
The role of fecal microbiota transplantation in ulcerative colitis and Crohn’s disease: results from a parallel inflammatory bowel disease cohort study (El-Nachef et al.) [view]
Does fecal microbiota transplantation from an obese donor lead to weight gain? A case series of 70 recipients (Fischer et al.) [view]
Fecal microbiota transplantation is safe and effective for the treatment of Clostridium difficile infection in solid organ transplant recipients (Fischer et al.) [view]
Should we recommend anti-Clostridium difficile antibiotic or probiotic prophylaxis? Risk of Clostridium difficile infection with systemic antimicrobial therapy following successful fecal microbiota transplant. (Fischer et al.) [view]
Fecal microbiota transplantation differentially influences the gut microbiota of Clostridium difficile infection and ileal pouch anal anastomosis patients. (Piceno et al.) [view]
The stool bank will also continue providing fecal transplant preparations to clinicians and researchers
SOMERVILLE, Mass. – OpenBiome, a public stool bank, announced today that it has entered into a collaboration with Finch Therapeutics, a microbiome biopharmaceutical company, to enable FDA approval of a fecal transplant pill for the treatment of recurrent C. difficile infection. Finch will be licensing OpenBiome’s biomanufacturing quality systems and incorporating manufacturing upgrades as well as its own drug delivery technology to prepare the product for clinical trials and eventual marketing authorization.
Since delivering its first treatment in October 2013, OpenBiome has distributed more than 21,000 treatments to its network of over 800 hospitals and clinics. Fecal microbiota transplantation (FMT) is used to treat C. difficile infections that are not responsive to antibiotic therapies. C. difficile is the most common hospital-acquired infection in the country, affecting 453,000 patients a year, and resulting in an estimated 29,000 deaths. 1 in 5 patients do not respond to first-line antibiotics. For patients who fail multiple courses of antibiotic treatment, fecal transplantation has been shown to prevent recurrence in more than 85% of cases.
OpenBiome was founded to expand safe access to fecal transplantation for patients with recurrent C. difficile infection and to catalyze research on the role of the microbiome in human health. The stool bank provides clinicians with rigorously screened, ready-to-use stool microbiota preparations and supports researchers with a suite of tools to discover how gut bacteria might treat diseases beyond C. difficile. When it launched, patients in need of fecal transplants often had to travel significant distances for a visit to one of the few fecal transplant practitioners in the country. Today, more than 97% of the US population lives within a two-hour drive of a provider using OpenBiome material to perform FMT.
An interim policy from the U.S. Food and Drug Administration (FDA) allows physicians to perform FMT for the treatment of recurrent C. difficile infection, despite the fact that the therapy is not FDA-approved. Medical professional societies and clinical researchers advocated for the policy based on the available literature on FMT’s safety and efficacy and the lack of treatment alternatives for this patient population.
“To preserve patient access to this treatment option, and given the scale that we’ve reached, demonstrating the safety and efficacy of fecal transplantation through adequate and well-controlled clinical trials is the right thing to do,” explained Carolyn Edelstein, OpenBiome’s director of Outreach and Public Affairs, in an op-ed published earlier today with the Fecal Transplant Foundation.
OpenBiome will continue to supply clinicians and researchers with material, manufactured by Finch, under prevailing FDA policy and in support of its nonprofit mission to enable patient access and research. Under the terms of the collaboration, OpenBiome will license its quality system for biomanufacturing to Finch. Finch will incorporate its novel drug delivery technology to enable the targeted release of microbes at the site of the C. difficile infection in the colon. Finch will also upgrade the manufacturing system to support FDA approval, and will provide material produced in this improved quality environment to OpenBiome.
FIN-403 is the lead product candidate emerging from this partnership. Finch expects to begin enrolling for a Phase II clinical trial to evaluate the safety and efficacy of FIN-403 for the prevention of recurrence in recurrent C. difficile patients in the second half of 2017.
OpenBiome will receive a series of upfront payments, ongoing milestone payments, and royalties on sales of FIN-403 and other products developed in the collaboration. With these resources, OpenBiome will support early-stage, high-risk, long-term microbiome research programs that might not be able to secure traditional funding. With this additional funding for its independent research program, OpenBiome will work to advance public knowledge on how gut bacteria can be engineered to help cure or even prevent disease.
Dr. Mark Smith, PhD, OpenBiome’s co-founder and research director, will be stepping down from his roles at OpenBiome to serve as the CEO at Finch. He will maintain a seat on the OpenBiome Board of Directors and serve as an advisor to OpenBiome’s Scientific Review Board.
“This affiliation will allow us to execute our mission at a level we could not have imagined before,” said James Burgess, OpenBiome’s Executive Director, in a letter to OpenBiome’s clinicians and researchers. “Through it, we will provide safe access to fecal transplantation for patients with recurrent C. difficile today, and help Finch pursue FDA approval so that patients have this access in perpetuity. OpenBiome will continue to catalyze research in the microbiome by providing clinical investigators with logistical and material support, and by facilitating the kind of discoveries that will help cure or even prevent disease. We are thrilled by the path ahead.”
For more details on this announcement, please see:
“It’s time for FDA-approved poo” by Catherine Duff and Carolyn Edelstein
An open letter to the clinicians and researchers we serve
A memo on the collaboration’s process and framework
OpenBiome is the first public stool bank, founded to expand safe access to fecal transplantation for patients with recurrent C. difficile infection and to catalyze research on the microbiome’s role in human health. OpenBiome provides clinicians with rigorously screened, ready-to-use stool preparations and supports researchers with a suite of tools to discover how gut bacteria might treat diseases beyond C. difficile. Since 2013, OpenBiome has partnered with over 800 healthcare institutions across all 50 states and 6 countries to deliver more than 21,000 treatments for recurrent C. difficile. Its research portfolio includes 49% of all U.S. trials exploring the use of fecal transplants in new diseases.
Finch Therapeutics is a mission-driven biopharmaceutical company that aims to develop novel microbial therapies serving patients with serious and unmet medical needs. Founded by data scientists, clinicians, and microbiologists from MIT and OpenBiome, Finch uses machine-learning algorithms informed by high-throughput molecular data to reverse engineer successful experiences with fecal transplantation. Through this and other clinical datasets, Finch identifies the microbes that drive desirable patient outcomes, and develops therapies that that deliver those microbial communities to the patient. As Finch’s first clinical-stage program, FIN-403 provides both a short-term opportunity for impacting C. difficile and a long-term platform for designing new therapies.
SOMERVILLE, Mass - OpenBiome, the first public stool bank, celebrated shipping its 20,000th fecal microbiota transplantation (FMT) preparation today for use in treating deadly Clostridium difficile (C. diff) infections. “We’re proud to have helped hundreds of clinicians help patients with recurrent C. diff infections, and we look forward to working with even more partners in 2017,” said James Burgess, OpenBiome’s executive director. “With more than 800 providers in 50 states, it’s clear that the medical community has taken ownership of this treatment.”
In the four years since OpenBiome provided its first treatment, it has grown to support hospitals and clinics with more than 1,000 FMT preparations per month. More than 453,000 Americans contract C. diff infections each year, and 29,000 die. When antibiotics fail to cure patients after multiple attempts, FMT has been found to cure 85% of antibiotic-resistant C. diff infections.
Thanks to a growing network of providers, 97% of Americans live within a two-hour drive of a treatment center offering FMT. OpenBiome also supplies material for 47% of the open clinical trials of FMT in the United States, supporting research on the therapy’s potential for treating conditions including ulcerative colitis, Crohn’s disease, and irritable bowel syndrome.
“This field is expanding rapidly,” said Mark Smith, OpenBiome’s research director. “What was a fringe treatment just five years ago is now standard, and we’re just beginning to explore how human health can be advanced through microbiome-based interventions. It’s exciting to be part of this research.”
For patients who have suffered with C. diff, the impact of a successful FMT can be profound. As one patient wrote, “I am 51 today. I was 42 years old when I was first diagnosed with cancer and when the diarrhea began. I have a lot of living yet to do, living a life that I had thought was nearly over, and is now just beginning again. My life is beginning again because I had the opportunity to have a fecal transplant from a stranger who came to my aid.”
OpenBiome is a nonprofit stool bank and research platform founded in 2012 to expand safe access to FMT and to catalyze research. For more information about FMT treatment, providers, and research, visit www.openbiome.org.
CAMBRIDGE, Mass — The gut microbiome has been investigated for decades, but researchers are just beginning to understand the many roles that microorganisms play in the human body, and how to use them to benefit human health. OpenBiome and the MIT Center for Microbiome Informatics and Therapeutics partnered to host the Second Annual Translational Microbiome Workshop, bringing more than 80 researchers and clinicians from 17 different institutions together to collaborate on unlocking the mysteries of the human microbiome.
Dr. Jeremiah Faith, PhD, of Mt. Sinai Medical Center, presented the first keynote address on his work building model systems for fecal microbial transplants (FMT) in mice and strain tracking for FMT in humans. Faith highlighted that the microbiome retains stable engraftment for months after an FMT, highlighting the need to investigate and understand long-term safety outcomes. He also sounded a cautionary note about the future widespread use of a single cocktail of synthetically grown microoganisms. In the second keynote, Dr. John Bartlett, MD, the celebrated founder of the Division of Infectious Diseases at Johns Hopkins School of Medicine, provided a clinical perspective on the historical emergence of both C. difficile and FMT. Dr. Bartlett’s team made the association between antibiotic-associated colitis and C. difficile at Tufts University in the 1970s, and his talk reviewed medical and public health approaches to managing the disease, including challenges in methods of detection and diagnosis. These methods included polymerase chain reactions, ELISA immunoassays, and even a dog’s sense of smell when, in the Netherlands, a trained beagle was able to accurately differentiate between hospital rooms with and without C. diff patients.
Following the keynotes, attendees broke up into smaller groups to tackle some of the most pressing obstacles and open questions facing microbiome researchers and clinicians. Some sessions focused on advances in basic science, such as new modeling techniques for host-microbe interactions or the Microbiome Metacommunity Standard developed by OpenBiome. Others offered opportunities for participants to discuss novel applications of microbial therapy, such as using FMT in malnutrition and tropical diseases.
Many of OpenBiome’s clinical research collaborators joined to share their expertise. Dr. Olga Aroniadis, MD, of Montefiore Medical Center led a discussion on the lessons learned from FMT trials in IBS, highlighting the disease’s complexity and how engineering the microbiome could achieve clinical improvements in patients. Dr. Marina Santiago of Finch Therapeutics gave an overview of the role the gut plays in the spread of antibiotic resistance and how FMT could serve to fundamentally disrupt the cat-and-mouse game of antibiotic overuse and resistance.
Other groups discussed the legal challenges facing the development of microbiome-targeted therapies. A session led by OpenBiome Director of Policy and Global Partnerships Carolyn Edelstein outlined the unique regulatory environment of the microbiome, while another led by Dr. Stephen Altieri, JD, PhD, tackled how intellectual property law will affect current and future therapeutic innovations.
The non-profit stool bank shared data from a 2,050 patient cohort of fecal transplant recipients and other research at the American College of Gastroenterology and the Infectious Disease Society of America annual meetings.
SOMERVILLE, Mass —OpenBiome, a public stool bank, presented new research on fecal microbiota transplantation (FMT) at the 2016 American College of Gastroenterology Annual Scientific Meeting and Infectious Diseases Week 2016. Among ten abstracts accepted to the two conferences were three on the safety and efficacy of FMT in the largest adult and pediatric Clostridium difficile (CDI) patient cohorts to date. In both populations, FMT continues to produce high cure rates and promising safety results.
Three of OpenBiome’s ACG abstracts were chosen as Posters of Distinction. Among them was OpenBiome Clinical Program Director Majdi Osman’s (MD, MPH) study of FMT in pediatric CDI, which showed a cure rate of 85.5% and no reported serious adverse events among 69 patients who received FMT. OpenBiome’s other Posters of Distinction reflected its success in increasing access to FMT—96.7% of the US population now lives within a 2-hour drive of a hospital or clinic that offers FMT—and provided valuable data about the safety of FMT. At a hospital with an internal stool-banking program, 31 patients received FMT from a donor who later developed Crohn’s disease, but none of the patients have subsequently developed inflammatory bowel disease themselves. Three additional posters showed that stool donors had a higher-than-average fiber intake relative to the average American, emphasized the importance of testing for toxin status in patients prior to initiating antibiotics, and highlighted the importance of patient education in preventing recurrence.
At ID Week, OpenBiome presented data from the largest FMT cohort reported to date. In an investigation of the safety and efficacy of FMT in 2,050 CDI patients, 84% of patients achieved clinical cure after FMT with no adverse events attributable to treatment. Another study—the largest yet to assess clinical efficacy for FMT in CDI by donor—found that there is no significant difference in cure rate from one donor to the next, reinforcing the utility and effectiveness of the stool bank model. An analysis of OpenBiome’s donor population also identified the most common reasons for donor exclusion, highlighting areas of particular importance for donor screening. OpenBiome also explored a new frontier of FMT research by presenting results which suggest that FMT and related microbial therapies may be effective in preventing infection and transmission of Vancomycin-resistant enterococcus, a dangerous multi-drug resistant bacteria, in high-risk settings.
ACG was held from October 14-19 in Las Vegas, NV, and ID Week was held from October 26-30 in New Orleans, LA. More information about OpenBiome, including its mission, patient stories, and Quality & Safety Assurance program, is available at www.openbiome.org.
Full list of OpenBiome and OpenBiome affiliate posters, ACG & IDWeek 2016
Empiric treatment of suspected recurrent Clostridium difficile infection (rCDI) with vancomycin may interfere with evaluation for fecal microbiota transplantation (Allegretti et al) [view]
Clearance of Vancomycin-Resistant Enterococcus (VRE) colonization with fecal microbiota transplantation among patients with recurrent Clostridium difficile infection (Eysenbach et al) [view]
Can You Cause Inflammatory Bowel Disease with Fecal Microbiota Transplantation? A 31-Patient Case Series of Fecal Transplantation Using Stool from a Donor Who Later Developed Crohn’s Disease* (Fischer et al) [NB: the donor was not a donor for OpenBiome] [view]
The impact of stool banks on access to fecal microbiota transplantation for recurrent Clostridium difficile infection in the United States: A geospatial analysis* (Kassam et al) [view]
Nutritional composition of stool donor’s diet relative to that of the U.S. population: Results from 44 donors form an international stool bank for fecal microbiota transplantation (O’Brien et al) [view]
Safety and efficacy of fecal microbiota transplantation for recurrent Clostridium difficile infection from an international public stool bank: Results from a 2050-patient multi-center cohort (Osman et al) [view]
The great mimic: Food-borne illness masquerading as an infectious adverse event following fecal microbiota transplantation (Osman et al) [view]
Donor efficacy in fecal microbiota transplantation (FMT) for recurrent Clostridium difficile: Evidence from a 1,999 patient cohort (Osman et al) [view]
Clinical effectiveness and safety of fecal microbiota transplantation in children for Clostridium difficile infection: Results from 9 pediatric centers in the United States* (Osman et al) [view]
Characterizing patients who fail fecal microbiota transplantation for Clostridium difficile infection (CDI): Results from a 135 patient, multi-center non-responder cohort (Razik et al) [view]
* = posters of distinction
Studies will explore use of fecal transplants to combat antibiotic resistance and prevent infection
Medford, MA -- New studies at OpenBiome could reveal how to prevent dangerous antibiotic-resistant infections using human stool. The Centers for Disease Control and Prevention (CDC) announced today that it is awarding OpenBiome two contracts totaling $1,050,000 to study fecal microbiota transplants in treating vancomycin-resistant enterococcus (VRE) and to explore the use of autologous fecal transplants, in which a patient receives their own banked fecal material to prevent intestinal infections following antibiotic treatments.
“Antibiotics are life-saving medicines, but they also can disrupt a person’s microbiome and increase the risk for drug-resistant infections,” says Dr. Clifford McDonald, Associate Director of Science for CDC’s Division of Healthcare Quality Promotion. “To protect people, their microbiomes, and the effectiveness of antibiotics, these projects are an example of applied research that has the potential to produce innovative public health approaches to better combat antibiotic resistance.”
OpenBiome’s first study will test fecal microbiota transplant (FMT) effectiveness in treating VRE. More than 66,000 patients contract VRE infections each year in the U.S., resulting in 1300 deaths. VRE has been designated a “serious threat” by the CDC because these infections are difficult to treat and expensive to cure. Currently there are no alternative treatments for VRE once antibiotic therapies fail.
In vitro, animal studies, and retrospective analyses in FMT patients suggest that the therapy could serve as a way to eliminate VRE from patients’ intestinal tracts, helping them to avoid dangerous infections. FMT introduces bacteria into the gut that outcompete the harmful bacteria, essentially crowding them out. By comparison, FMT treatments with stool from healthy donors cure 80-90% of patients with antibiotic-resistant Clostridium difficile gut infections who have failed two or more rounds of antibiotic treatment.
OpenBiome’s second contract will fund a study of autologous (self) FMT treatment in preventing infection. Elderly residents of long-term care facilities are particularly vulnerable to antibiotic-resistant bacteria colonization and infection. On average 35% of nursing home residents will develop an infection requiring antibiotic treatment each year.
For this study, OpenBiome will collect stool samples from nursing home residents whose feces test negative for antibiotic-resistant bacteria. After these residents have completed a course of antibiotics, they will be given either FMT capsules filled with their own stool, or a placebo. They will then be evaluated for safety, gut microbial diversity, and prevention of colonization by antibiotic resistant bacteria. If the results are promising, OpenBiome will follow up with a larger trial of autologous FMT for preventing enteric (gut) antibiotic-resistant infections among high-risk patients.
“We’ve been fighting antibiotic resistance by developing increasingly toxic drugs, but we’re engaging in an evolutionary arms race with bacteria that we can’t win” says Mark Smith, President and Research Director of OpenBiome. “With these trials, we’ll explore whether we can use the protective community of bacteria found in a healthy gut do the work for us.”
The awards, made through CDC’s Broad Agency Announcement (BAA), support the CDC Antibiotic Resistance Solutions Initiative and help to advance the objectives articulated in the National Action Plan for Combating Antibiotic-Resistant Bacteria.
OpenBiome is a nonprofit stool bank and research platform. We work collaboratively with clinicians, hospitals, and researchers to make fecal microbiota transplantation (FMT) safe and affordable for patients suffering from recurrent C. difficile infection and to explore FMT's role in treating other diseases.
Before OpenBiome, the only way for patients to access the procedure safely was by finding their own donor who could pass an expensive panel of screens and a clinician willing to prepare and deliver the stool treatment. Many patients resorted to performing the procedure themselves at home, at the risk of contracting new infections. Since sending its first treatment in Oct 2013, OpenBiome has provided more than 16,000 treatments to clinicians at over 700 medical centers in every U.S. state and in 6 countries. OpenBiome is also supporting 13 actively enrolling clinical trials to explore the potential role for gut bacteria in improving human health.
Donors can help cure patients suffering from dangerous infection and earn financial compensation for their commitment
Somerville, MA – OpenBiome, a nonprofit stool bank, is seeking healthy individuals to enroll as stool donors at its new clinical site near Sullivan Square, in Somerville, MA. Individuals are also still able to donate at OpenBiome’s current site in Medford.
The stool samples will be used to treat patients suffering from recurrent episodes of C. difficile infection, the most common hospital-acquired infection in the U.S., and the cause of 30,000 deaths each year. Patients are treated with a procedure called a fecal transplant, in which a physician infuses stool from the healthy donor into the patient’s colon. Where antibiotics are only effective 30-40% of the time for these patients, fecal transplants have a cure rate of 80-90%.
The stool donations will also be used in clinical research across the U.S., exploring the use of fecal transplants and other microbiome-based therapies for the treatment of a range of diseases, including ulcerative colitis, Crohn’s disease, irritable bowel syndrome, and others.
Donors are expected to enroll in the program for a minimum of two months, during which they will visit the OpenBiome clinic in Medford or Somerville 4-5 times per week to contribute stool. Donors will be compensated $40 per stool sample that they contribute during the program.
Donors are selected through a rigorous screening process that evaluates their health status and medical history. After joining the online donor registry, those who are eligible are invited in for a clinical interview, which is followed by blood and stool screening. Donors also undergo regular health screening throughout their participation in the program. Only those who can visit an OpenBiome location most days of the week will be eligible to apply. More information about selection criteria and how to become a stool donor is available at www.openbiome.org/stool-donation/.
OpenBiome is a nonprofit stool bank dedicated to expanding safe access to fecal microbiota transplantation and catalyzing research in the human microbiome. Founded by a team of microbiologists and public health advocates out of MIT, OpenBiome has facilitated more than 13,000 fecal transplants across 600 hospitals in all 50 U.S. states and 6 countries. With the new Somerville branch, an even broader pool of qualified donors will be able to help deliver this transformative treatment to patients.
Nonprofit stool bank support four clinical trials investigating the efficacy of FMT in treating Inflammatory Bowel Disease (IBD)
Medford, MA – Researchers at OpenBiome are supporting four clinical trials investigating the safety and efficacy of fecal microbiota transplantation (FMT) in treating patients with inflammatory bowel diseases (IBD), including Crohn’s disease and ulcerative colitis. Led by researchers from Cornell University, Beth Israel Deaconess Medical Center, the University of Vermont, and the University of California in San Francisco, these studies have all begun recruiting patients and will be important steps for our collective understanding of how FMT can be used to treat new indications beyond C. difficile.
FMT is a procedure in which a stool preparation from a healthy human donor is infused into the colon of a patient, most often via colonoscopy, enema, or a plastic tube inserted through the nose leading to the intestines. FMT has long been established as an effective therapy for the treatment of recurrent Clostridium difficile infection, with a cure rate of 85-90% across multiple randomized controlled trials. Growing evidence suggests FMT may also be a powerful treatment for IBD patients, who currently have few effective treatment options.
Included among the four IBD studies are two randomized controlled trials led by Dr. Peter Moses of the University of Vermont and Dr. Alan Moss of Beth Israel Deaconess Medical Center. Moses is conducting a double-blind randomized study evaluating the safety and efficacy of FMT in a sample of 20 patients with ulcerative colitis. Moss is leading a multi-center randomized trial (n=44) in collaboration with Brigham & Women’s Hospital, Boston Medical Center, and the Massachusetts Institute of Technology to determine if FMT can safely alleviate the debilitating symptoms of Crohn’s disease in patients who have had intestinal resection.
Additionally, OpenBiome is supporting two prospective pilot studies led by Dr. Carl Crawford of Cornell University and Dr. Najwa El-Nachef of the University of California-San Francisco. These single group studies aim to explore whether FMT can safely control the symptoms associated with inflammatory bowel disease. While Elnachef’s study is enrolling patients (n=60) with various forms of IBD, Crawford is focusing on FMT’s long-term safety in managing ulcerative colitis patients (n=20) specifically.
Patients who are looking for more information on how to enroll can view these studies by clicking on the researchers’ names above and find more details on clinicaltrials.gov.
Since its launch in 2012, OpenBiome has been dedicated to expanding safe access to FMT for patients suffering from recurrent C. difficile infections and catalyzing research into the microbiome and its role in human health. Given the increasing connection between the microbiome and IBD, OpenBiome is excited to push forward its mission by collaborating with leaders in the field of fecal microbiota transplantation to discover new applications of FMT that may help improve quality of life for patients living with Crohn’s or ulcerative colitis.
Nonprofit stool bank hosts workshop with researchers from the MIT Center for Microbiome Informatics & Therapeutics
MEDFORD, Mass – Researchers from OpenBiome, the first public stool bank, and the MIT Center for Microbiome Informatics and Therapeutics brought together over 60 members of Boston’s clinical research community to discuss the current state of translational microbiome research.
As the name suggests, translational research aims to apply insights from basic science to improve clinical care and patient outcomes, closing the gap from research “bench-to-bedside.” During the workshop, physicians, scientists, students and public health advocates shared their current research projects and brainstormed solutions to problems facing translational research in this space.
The workshop was held the Broad Institute at MIT, commencing with a keynote address from Dr. Alan Moss, a leading researcher and gastroenterologist from Beth Israel Medical Center, whose work focuses on finding new applications of fecal microbiota transplantation for inflammatory bowel diseases. He spoke about the importance of designing effective clinical trials that measure objective end points and consider long-term follow up.
OpenBiome and MIT researchers organized this workshop to bring together the microbiome research community in Boston. Participants engaged in interactive group discussions, addressing topics such as “Law & the Microbiome” and “Microbiome Discoveries.” They also formed small groups to discuss challenges facing translational research and shared the outcomes of their brainstorming sessions with the larger audience. One group, tasked with the question of how to find donors for FMT in other indications, came up with a two step solution: First, “find donors that work and [then] study the heck out of them.”
Other presentations included Elaine Vo, PhD, who discussed OpenBiome’s capabilities for providing cutting-edge research tools, including the new FMT Capsule G3, a fecal transplant pill that offers the first non-invasive delivery method for C. difficile patients. Other key presenters included Eric Alm PhD, an Associate Professor of Biological Engineering at MIT, and Mark Smith PhD, co-founder and Research Director of OpenBiome.
“We were thrilled to bring together some of the field’s leading researchers for a day of educational discussions and collaboration,” said Dr. Mark Smith, PhD, Research Director at OpenBiome. “Translational microbiome research is poised to unlock unprecedented therapies and diagnostics to help patients with a range of diseases. By bringing together the best minds in this space, we hope to work together to make these possibilities reality.”
To learn more details about the day’s presentations and discussions, please contact the workshop’s coordinator Lindsay Eysenbach at email@example.com.
Focus on FMT and the Universal Stool Bank Model in the Gastroenterology and Infectious Disease Communities
MEDFORD, Mass -- OpenBiome’s research team recently presented multiple oral plenaries and posters on research into fecal microbiota transplantation (FMT) at both Infectious Disease Week 2015 and the American College of Gastroenterology 2015 Annual Scientific Meeting. OpenBiome’s abstracts were selected from hundreds of submissions, and covered topics that included the efficacy and cost-effectiveness of microbiota treatments for recurrent Clostridium difficile, and OpenBiome’s patented capsule delivery method.
OpenBiome, a nonprofit stool bank dedicated to expanding safe access to fecal microbiota transplants (FMT), provides treatments for patients with recurrent Clostridium difficile (rCDI), as well as other diseases investigated through clinical trials. OpenBiome aims to significantly reduce the practical barriers for clinicians providing FMTs, while supporting research scientists and physicians using FMTs or investigating the role of the microbiome in human health.
Reflecting a new emphasis on the importance of FMT within the field of gastroenterology, ACG hosted a key session evaluating studies and outcomes of the procedure. Colleen Kelly, MD, FACG, a member of OpenBiome’s Clinical Advisory Board, led the discussion with the results of her randomized, placebo-controlled, double-blind study which demonstrated that “FMT administered via colonoscopy was significantly more effective than placebo.”[i]
Also at ACG, Zain Kassam, MD, MPH, Chief Medical Officer at OpenBiome, was selected to give an oral plenary on the cost-effectiveness of providing FMT through OpenBiome’s universal donor model, demonstrating an incremental direct cost savings of up to $3,661 compared to vancomycin (the standard antibiotic treatment for rCDI).[ii] Additionally, OpenBiome’s poster entitled “Microbial Emulsion Matrices: A Novel Method to Produce Stable, Orally Available Capsules for Fecal Microbiota Transplantation to Treat Clostridium difficile,” covered the technology that OpenBiome developed, enabling the first scalable capsules.[iii] OpenBiome’s second poster, “Novel Safety Features in [FMT] for [rCDI]: Quality Assurance and Adverse Events Workflow,” showcased OpenBiome’s next-generation safety program.
At ID Week, OpenBiome’s poster presentation on donor selection was also included in Posters in the Park, a program designed to highlight promising work to thought leaders in the infectious diseases space. Entitled “Prospective Assessment of Donor Eligibility for Fecal Mirobiota Transplantation at a Public Stool Bank: Results From the Evaluation of 1,387 Candidate Donors,” this poster covered the rigorous screening criteria OpenBiome utilizes for selecting stool donors, and shared the most common issues for which prospective donors are excluded.
The ACG conference was held in Honolulu, Hawaii, from October 16th-21st, and ID Week was held from October 7th-11th in San Diego, CA. More information about OpenBiome, including its mission, patient stories, and Quality & Safety Assurance program, is available at openbiome.org.
Nonprofit stool bank launched by MIT researchers will provide the first fecal transplant pill for clinical use
MEDFORD, Mass — A new pill created by a team of MIT-trained researchers provides fecal transplant therapy without requiring the traditional, more invasive stool delivery methods.
The FMT Capsule G3 pills will serve as a treatment option for recurrent Clostridium difficile infections (rCDI) that don’t respond to standard antibiotic treatment. The pill will also serve as a new tool for researching future applications of microbiome-based therapies.
Fecal microbiota transplantation, or FMT, is procedure in which a stool preparation from a healthy human donor is infused into the intestine of a patient. It is typically delivered via colonoscopy, enema, or a plastic tube inserted through the nose into the stomach or intestines.
Delivering fecal microbiota transplantation by pill reduces both the procedural costs and risks associated with the more invasive delivery methods. It was the strongly preferred by patients in a survey published in Clinical Infectious Diseases.
The pill was created by OpenBiome, a nonprofit stool bank dedicated to expanding safe access to fecal microbiota transplantation therapies and catalyzing research into the human microbiome. Founded in 2012 by a team of microbiologists, clinicians, and public health advocates from Harvard and MIT, OpenBiome has since provided over 7000 treatments to more than 450 clinical partners across six countries, and has supported 10 clinical and translational research studies.
OpenBiome’s FMT Capsule G3 uses a patent-pending Microbial Emulsion Matrix (MEM) technology, which preserves the viability of complex bacterial communities while ensuring capsules’ long-term physical stability. This feature allows for widespread provision of a fecal transplant pill—encapsulation methodologies used in the field to date have yielded capsules that degraded within minutes. The MEM technology was presented at the American College of Gastroenterology’s annual scientific meeting on October 18th.
Fecal microbiota transplantation has been shown across multiple studies to be 89 percent effective in treating Clostridium difficile infection, while standard antibiotic therapies yield cure rates of less than 40 percent. C. difficile is the most common hospital-acquired infection in the U.S., and one in five patients with C. difficile will have to endure the infection more than once.
Results from a pilot, multi-center randomized dose-finding study with 17 patients led by Dr. Monika Fischer, MD, MSCR, Clinical Assistant Professor of Medicine at Indiana University, and Dr. Jessica Allegretti, MD, MPH, associate gastroenterologist at Brigham and Women’s Hospital and instructor of medicine at Harvard Medical School, found an initial efficacy rate of 70 percent in both low and high dose groups receiving OpenBiome’s FMT capsules. Treatment with a high dose after an initial nonresponse yielded an aggregate clinical cure rate of 94 percent. There were no adverse events reported.
The results, presented on Monday morning at an award-winning late-breaking oral presentation at United European Gastroenterology Week in Barcelona, Spain, are comparable to previously published investigations of the efficacy of encapsulated FMT. The abstract may be viewed using the conference’s online program tool.
“This is a compelling step towards providing evidence-based FMT capsule treatments for patients,” said Dr. Zain Kassam, MD, MPH, Chief Medical Officer of OpenBiome. “Although colonoscopic delivery remains the gold standard for FMT in terms of efficacy, these results suggest that FMT capsules may emerge as an effective and less invasive therapy option. We hope to help usher in a universe in which patients suffering from this crippling diarrheal infection have safe access to FMT without having to undergo a procedure.”
Similar to other microbiota preparations already provided by OpenBiome, FMT Capsule G3 may be used to treat patients with rCDI under the FDA's enforcement discretion guidelines, or to treat other conditions under an Investigational New Drug application. Encapsulated FMT is a particularly useful tool for clinical research because it allows investigators to evaluate maintenance FMT therapy without requiring participants to undergo repeated invasive procedures.
“OpenBiome’s FMT Capsule G3 is a major step forward for FMT patients, physicians, and clinical researchers because it reduces the procedure-related risks and discomforts of FMT,” said Dr. Mark Smith, PhD, Research Director at OpenBiome. “We have already seen the remarkable impact of standardizing FMT for the treatment of rCDI through traditional routes of administration, and we are thrilled to add capsules as a new option to further expand patients’ safe access to care.”
To learn more about OpenBiome’s FMT Capsule G3, please visit www.openbiome.org/fmtcapsules.
Medford, Mass – A new pilot service launched at OpenBiome, the first and largest public stool bank, will allow individuals to cryogenically preserve a sample of their fecal microbiota. In the event that they require a fecal transplant for the treatment of recurrent C. difficile infection, participants may use their banked samples for the procedure.
Fecal microbiota transplantation, or FMT, is a procedure in which a stool preparation from a healthy human donor is infused into the colon of a patient. It’s typically delivered via colonoscopy, enema, or a nasogastric tube.
Fecal microbiota transplantation has been shown across multiple studies to be 89 percent effective in curing Clostridium difficile infection, while standard antibiotics yield cure rates of less than 40 percent. C. difficile is the most common hospital-acquired infection in the U.S., and one in five patients with C. difficile will have to endure the infection more than once.
OpenBiome is a nonprofit stool bank dedicated to expanding safe access to fecal microbiota transplantation and catalyzing research into the human microbiome. Founded in 2012 by a team of microbiologists, clinicians, and public health advocates from Harvard and MIT, OpenBiome has since provided over 7,000 treatments to more than 400 partner medical centers in six countries, and has supported 10 clinical and translational research studies.
OpenBiome’s stool banking model provides rigorously screened material from universal stool donors for the treatment of recurrent C. difficile infections. However, there may be advantages to repopulating an individual’s gut with their own healthy microbial community, withdrawn from their PersonalBiome bank. PersonalBiome participants will also be eligible to receive a range of customized screening, sequencing, consultation, processing, encapsulation, and cryopreservation services.
OpenBiome will also work with hospitals and clinics serving patients who are at higher risk of contracting the infection to facilitate their participation in the new program.
“We’re thrilled to offer OpenBiome’s bio-banking services to individuals for their personal use,” said James Burgess, Co-founder and Executive Director of OpenBiome. “While we remain committed to treating patients with recurrent C. difficile following our universal donor model, we are pleased to respond to growing demand for a service that allows individuals to undergo FMT treatment with their own unique microbial communities.”
Individuals or hospital representatives who wish to learn more about participating in the PersonalBiome pilot launch should contact firstname.lastname@example.org and refer to www.openbiome.org/personalbiome.
OpenBiome is a nonprofit stool bank dedicated to expanding safe access to fecal microbiota transplantation (FMT) therapies. Founded by a team of microbiologists, public health advocates, and concerned citizens, OpenBiome aims to significantly reduce the practical barriers for clinicians providing FMTs, while connecting scientists across studies and disciplines.
Update May 25th, 2018:
OpenBiome is no longer providing fecal microbiota transplantation (FMT) material to the European Union (EU) due to the General Data Protection Regulation (GDPR) that went into effect May 25, 2018.
The stool bank is working with the APC Microbiome Institute in Cork, Ireland to bring rigorously screened, ready-to-use fecal microbiota preparations to European patients suffering from recurrent C. difficile infections.
Cork, Ireland – OpenBiome announced today that it will make its microbiota preparations for fecal microbiota transplantation (FMT) available to patients across Europe suffering from recurrent C. difficile infections.
C. difficile, one of the most common hospital-acquired infections, is an aggressive intestinal illness that can cause debilitating and potentially life-threatening diarrhea. C. difficile infects an estimated 145,000 people in the EU each year. Each case costs between €5,000-€15,000 to treat, resulting in estimated costs of over €3.7 billion annually to European healthcare systems.
FMT is a powerful treatment option for this infection. While standard antibiotic therapies resolve multiply recurrent C. difficile infection about 30% of the time, FMT has a cure rate of 85-90%. However, the expense and inconvenience of finding and screening suitable stool donors often limits the use of FMT.
OpenBiome, a nonprofit stool bank, overcomes barriers by providing hospitals and clinics with rigorously screened fecal microbiota preparations. By dividing the donor screening costs across multiple treatments prepared from each donor, OpenBiome provides treatments for a fraction of the cost of either a physician-directed process or of antibiotic treatment options. Founded by a team of microbiologists and public health advocates at MIT, OpenBiome has facilitated more than 5,000 fecal transplants across 350 hospitals in 49 U.S. states and 6 countries.
OpenBiome is collaborating with the Alimentary Pharmabiotic Centre (APC) Microbiome Institute, a research center based at the University College Cork, to work with clinicians, researchers, and regulators to adapt OpenBiome’s stool banking model to the European context, and import its microbiota preparations beginning in Ireland and the UK.
European physicians who are interested in using OpenBiome’s material to treat C. difficile patients or to conduct research studies should contact email@example.com.
After experiencing a rapid growth in demand for its clinical treatments, OpenBiome is on track to treat 1-in-10 patients in the U.S. suffering from C. difficile by end of year.
Medford, MA - Following only ten months after marking 1000 treatments provided, OpenBiome shipped its 5000th treatment for recurrent Clostridium difficile yesterday.
C. difficile, one of the most common hospital-acquired diseases, infects roughly half a million Americans every year, with 30,000 deaths as a result. While often initially treatable with antibiotics, about 1 in 5 patients experience multiple recurrences. OpenBiome’s fecal microbiota preparation (FMT) is used to treat recurrent C. difficile at over 400 partner hospitals across the country. FMT involves transplanting carefully screened, processed stool from a healthy donor into a sick patient’s colon.
With FMTs shown to be around 90% effective across several clinical studies, providing heavily screened, processed treatments at-cost is essential to lowering the access barrier and making an impact on the prevalence of C. difficile. As such, OpenBiome last year announced its initiative to treat 1 in 10 patients across the U.S. suffering from recurrent C. difficile.
“Reaching 5000 treatments so quickly after OpenBiome’s 1000th treatment supplied, this marks a milestone in OpenBiome’s rapid expansion over the past two years,” said James Burgess, co-founder and Executive Director. “This success is on track with OpenBiome’s projections for the necessary growth to provide treatments for 1-in-10 patients in the U.S. with recurrent C. difficile by end of year, making a significant impact on this national health burden.”
The rapid growth of this service is due to the ease and cost-effectiveness for physicians using OpenBiome material. Providing at-cost, rigorously screened material takes the burden off the physician to find and coordinate with an eligible donor, and to process the fecal material. OpenBiome is committed to simplifying and lowering the cost of FMT, to enable access and thereby combat the spread of recurrent C. difficile.
Researchers at nonprofit stool bank begin recruiting participants for study investigating the long-term safety of FMT for treating recurrent C. difficile
Medford, Mass – Researchers at OpenBiome have launched a clinical trial investigating the long-term safety and efficacy of fecal microbiota transplantation (FMT) for treating patients with recurrent Clostridium difficile infection (rCDI) that is not responding to standard antibiotic therapies. Called the STOOL study, this trial is an important step forward for the field as it seeks to provide data-driven evidence to support the long-term safety profile of FMT.
FMT is a procedure in which a stool preparation from a healthy human donor is infused into the colon of a sick patient. It is typically delivered via colonoscopy, enema, or a plastic tube inserted through the nose leading to the intestines. While antibiotics can yield cure rates of less than 40%, FMT has been shown across multiple studies to be 89% effective in treating rCDI. However, studies so far have focused on short-term safety and efficacy outcomes, leaving open questions about the long-term safety profile of a treatment that medical societies advocate as the standard of care for treating rCDI.
The study, titled “Safety of fecal microbiota Transplantation: OpenBiome Outcomes and Longitudinal follow-up for recurrent Clostridium difficile” (STOOL) will be the first to provide long-term safety data for patients who have undergone an FMT for the treatment of rCDI. Dr. Colleen Kelly of Brown Medical Center enrolled the first patients this year, and six other clinical sites are on track to begin recruiting next year. Study collaborators aim to enroll a total of 150 participants, who will be followed for one-year post-FMT procedure.
Adults who have had 3 episodes of C. difficile infections and have not experienced long-lasting clinical resolution following antibiotic therapy are eligible to participate. They will receive an FMT administered by lower delivery, most often by colonoscopy or enema, and then be monitored for one year. At various follow-up points, research staff will contact them to determine if their C.difficile-associated symptoms have resolved, examine their stool microbiome, and assess if they have experienced any negative symptoms or health events that may be attributed to FMT. Beyond long-term safety, the results will also be able to tell if there is a microbial signature that predicts a clinical response, non-response or, if they occur, an adverse event.
“This multi-center, prospective longitudinal study will help inform our collective understanding of the long-term safety of this exciting microbial therapy,” says Dr. Zain Kassam, Chief Medical Officer at OpenBiome. “The body of evidence in this field suggests FMT is a safe intervention and many medical societies advocate for FMT as the standard of care for treating patients with recurrent C. difficile. However, no study has yet rigorously evaluated the long-term safety profile of FMT. We initiated the STOOL study because we believe it will be an important step to validate the promising outcomes clinicians have seen at the patient’s bedside.”