2016

Second Annual MIT-OpenBiome Translational Microbiome Workshop facilitated multi-disciplinary conversation on the search for novel microbial therapies

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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 full program of the event can be found on OpenBiome’s website at www.openbiome.org/mit-ob-2016. To learn more details about the workshop and content of individual sessions, please contact the event’s coordinator Tom Leith at tom@openbiome.org

OpenBiome presented data on safety and efficacy of fecal transplants and other new research at ACG & ID Week

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.

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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

CDC awards OpenBiome $1M in research contracts

Studies will explore use of fecal transplants to combat antibiotic resistance and prevent infection

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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.

About OpenBiome:

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.

 

Contact: media@openbiome.org

Twitter: @OpenBiome

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OpenBiome seeks stool donors at its new Somerville location

Donors can help cure patients suffering from dangerous infection and earn financial compensation for their commitment

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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. 

 

Contact: media@openbiome.org

Twitter: @OpenBiome

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OpenBiome-sponsored IBD studies begin enrolling patients

Nonprofit stool bank support four clinical trials investigating the efficacy of FMT in treating Inflammatory Bowel Disease (IBD)

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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.  

 

Contact: media@openbiome.org

Twitter: @Openbiome

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