It's Time for FDA-Approved Poo

In an op-ed in the Huffington Post, Catherine Duff, founding president of the Fecal Transplant Foundation and Carolyn Edelstein, director of outreach and public affairs at OpenBiome, reflect on OpenBiome's announcement of its collaboration with Finch Therapeutics and on how an FDA-approved microbiota treatment for recurrent C. difficile infection would transform patient care. 

View the op-ed here. 

Banking on stool despite an uncertain future

Tina Amirtha from Science discusses the regulatory future of fecal transplants, and how universal stool banks like OpenBiome could continue to make an impact. Here's an excerpt from the article:

"Whatever the commercial future of FMTs, the stool banks say they’ll have other work to do. OpenBiome may focus more on research, Edelstein says. Besides stool, OpenBiome provides guidance on experimental designs, safety protocols, and IND applications. The Leiden bank seeks to advance science as well. It just started a research collaboration with Vedanta Biosciences, and it plans to study whether fecal transplants should be given to C. difficile patients at an earlier stage. “Now, patients receive [an] FMT when they have tried all the other options,” Kuijper says. “But more can easily benefit.” 

Click here for the full article. 

OpenBiome feat. in the National Post

The National Post's Catherine McIntyre interviews OpenBiome co-founder Dr. Mark Smith for a feature on the rising demand for fecal tranpslants in Canada. See the full article here!

An excerpt from the article: "Passing a stool-screening test may be the hardest part of the process. “It’s actually more difficult than getting into Harvard,” says Smith. Only about four per cent of people who volunteer to be stool donors pass the three-step screening process, which involves a questionnaire, and stool and blood test, meant to rule out the presence of any known pathogens. (It’s easier to pass the mail-in variety lab test, which collect much less information.)

Despite the rigorous screening process, OpenBiome still manages to collect enough stool to supply 371 clinics and hospitals in 48 states and five countries. The bank collected its first sample in October 2013 and treated six patients by the end of the year. In 2014, they treated 2,000 patients, and by now they’ve provided stool for 5,419 treatments, and counting. “I didn’t really anticipate that it was going to grow as quickly as it has,” says Smith. And while there’s a distinct ick factor tied to his product, Smith says the stuff sells itself. “What’s kind of crazy about this thing is I sent out one email to a group of clinicians who were doing fecal transplants, and since then we’ve just been responding to requests.”"

WBUR covers OpenBiome's new FMT Capsule G3

Gabrielle Emanuel from Boston's NPR Station, WBUR,  covers OpenBiome's launch of the FMT Capsule G3 - the first publicly available poop pill used to treat C. difficile infection. Here's an excerpt from the article:

"OpenBiome, the nation’s first stool bank, is beginning large-scale production of a poop pill. This week marks the first time such a pill will be commercially available to hospitals and clinics.

Early tests suggest the pill is highly effective and comparable to traditional, more invasive delivery methods — for instance via colonoscopy, enema or a plastic tube through the nose and into the stomach or intestines.

'Fecal transplants came from what used to be this dark art — where you needed a donor and a blender,” says Mark Smith, research director at OpenBiome and one of its founders. “And now you basically take something out of the freezer and can treat the patient immediately. I’m very, very excited about this.'"

Click here for the full article.

OpenBiome feat. on Mic.com

Alexis Kleinman of Mic.com interviews OpenBiome members Dr. Mark Smith and Carolyn Edelstein, exploring the possibilities of treating patients with OpenBiome's newest treatment option: poop pills. Here's an excerpt: 

"This latest advancement could change lives. Instead of a colonoscopy, enema or tube up the nose, C. diff can now be treated by swallowing a small capsule. 

Yes, the pills are actually filled with poop. They contain essentially healthy fecal matter covered in an oil layer to protect the capsule, Edelstein said. Like the traditional FMT liquid, the pills are frozen to protect the bacteria.

You need a good sense of humor if you're going to work with poop all day. When Smith tells people about his line of work, "it usually leads to a very long conversation," he said. "It's very fun." People get excited about it — "maybe too excited about it," Smith continued. "People ask, 'What's it like to mail poo to strangers?'"

Read the full article here.

Save Your Microbiome for a Rainy Day

Jessica Leber from FastCompany interviews OpenBiome Co-founder and Executive Director James Burgess about OpenBiome's new personalized microbiome banking service, PersonalBiome. Take a look!

An excerpt from the article: "Many of these transplants, which now only require swallowing a pill, have been done with OpenBiome’s material. The group serves as a repository and screening facility for willing "poop donors" and has provided safe transplant material to 7,000 patients. Now, it is piloting a new service called PersonalBiome, which will allow people who are vulnerable to C. diff infections to proactively save their own microbiome for a rainy day. Burgess compares it to the way a woman might freeze her eggs, if she’s worried about her future fertility."

Find out about how to participate in OpenBiome's pilot launch of PersonalBiome here

The New York Times explores the new FMT Capsule G3

Peter Andrey Smith reported on the launch of FMT Capsule G3 for today's New York Times (headlined "Waste As Its Own Solution" in the print edition, and "Fecal Transplants Made (Somewhat) More Palatable" online).  Take a look!

An excerpt from the piece:

Dr. Jessica R. Allegretti, a physician at Brigham and Women’s Hospital in Boston, is putting together trials of the capsules against Crohn’s disease, obesity and primary C. difficile.

“It really does reduce the time from evaluation to procedure. It really does broaden who can get treated on a much larger scale, and for that, capsules are the wave of the future,” she said — especially, she added, for disorders that appear to require multiple treatments, or “maintenance” doses.

OpenBiome feat. in the NYT: "Should We Bank Our Own Stool?"

Reporter Moises Velasquez-Manoff from the New York Times writes about the possibilities of autologous stool banking and the pilot launch of OpenBiome's personalized microbiome banking service, PersonalBiome.

He asks, "Why, I wondered, didn’t doctors work harder to prevent this collateral damage, not with store-bought probiotics, but with “microbial restoration”? Why didn’t we reinfuse patients with their own microbes after antibiotics?"

Read the full article here.

Find out about how to participate in OpenBiome's pilot launch of PersonalBiome here

OpenBiome featured in The Irish Times

'Stool bank' may be answer to recurrent gut infections

Claire O'Connell from The Irish Times interviews Carolyn Edelstein, Director of Global Partnerships at OpenBiome, discussing the promise of Fecal Microbiota Transplantation, the advantages to OpenBiome's stool banking approach, and navigating the regulatory environment as OpenBiome seeks to expand into Ireland and the UK. On this last point, Edelstein comments:

'It’s a landscape that Openbiome needs to navigate, says Edelstein, but she sees advantages in going the repository route. 'In addition to being selective about the stool that we use, we can monitor the use of stool and follow up with patients a lot more systematically on a much broader scale,' she says. 'Also, we can source donors and use them over multiple treatments, so we can spread the cost of finding donors.'"

Ms. Edelstein will speak at a symposium at the APC Microbiome Institute in Cork this week. 

Click here to read the full article in The Irish Times. 

 

Poop Transplants and Microbiome Makeovers

Jessica Leber from FastCompany writes about the future research directions and applications of FMT. Here is an excerpt from her interview with OpenBiome's co-founder, Mark Smith: 

"When I talk to Smith, he seems relieved that I don’t want to talk about how he is paying people for their poop (that story’s been done, and done, and done.) I wanted to talk about where the poop was going. Because OpenBiome isn’t just sending raw material for C. diff patients: For investigators who have applied for and received the FDA’s approval, it’s also assisting in a growing number of clinical trials for many other kinds of diseases. A U.S. government database of current clinical trials around the world lists 82 results for "fecal matter transplant" related to conditions as diverse as liver diseasemetabolic syndrome and obesityHIVCrohn’s diseasepancreatitis, and Type 2 diabetes.

'I think there’s a lot of hype in this space. A lot of people look at the success that we have had for C. difficile, and think it will work 90% of the time for more complicated conditions. But if even a fraction of the hype is true—and I think it probably will be—then that’s going to have a huge impact,' says Smith."

Read the full article here.

OpenBiome featured on BBCTwo programme Trust Me, I'm a Doctor

From the BBC: "Surgeon Gabriel Weston travelled to Rhode Island in the US to watch Dr Colleen Kelly perform a faecal transplant — a procedure that has a 90% success rate when used to treat the life-threatening bacterial infection Clostridium difficile.

It is vital that the poo being used in the transplant is properly screened for infections and disease and it’s actually much harder to be a poo donor than you might think. At Open Biome in Boston, a non-profit company that provides screened, filtered and frozen poo for clinical use, only 6% of potential donors make it through the rigorous testing programme." 

To read more, click HERE.   UK audiences may watch the clip HERE.  

OpenBiome's stool donation program in the Washington Post

From the article by Rachel Feltman: "It's harder to become a donor than it is to get into MIT," joked co-founder Mark Smith (who would know, as he got his PhD in microbiology there). Of the 1,000 or so potential donors who've expressed interest on his Web site over the past two years, only about 4 percent have passed the extensive medical questioning and stool testing.

The screening process can cost up to $5,000 -- so when someone makes it through, Smith and his co-founders hold on tight.

"We get most of our donors to come in three or four times a week, which is pretty awesome," Smith said. "You're usually helping three or four patients out with each sample, and we keep track of that and let you know."

Read it here

Two Men Behind Fecal Transplants

Prevention Magazine featured an interview with OpenBiome co-founders James Burgess and Mark Smith in its January 2015 issue.  Nina Ellis sat down with Mark and James to chat about the messy details of banking stool, poop pills, and the future of the microbiome in medicine.  Here is an excerpt: 

NE: Is the future of good health really in the form of poop pills?
JB & MS: When it comes to personalized medicine, this is about as personal as it gets, right? It’s definitely the beginning of engineering the microbiome; a lot of the excitement is there are so many conditions—from gastrointestinal issues to obesity to depression—that are associated with the microbiome. It's a crude way of doing it, taking everything you’ve got and putting it in someone else. We're just really scratching the surface on how to do this type of engineering and ultimately this will have broad reaching effects on how we improve everyday health, treat infectious diseases, or more complex conditions.

Here is the piece in full. 

Mark Smith named to The Verge Top 50

OpenBiome co-founder Dr. Mark Smith has been named one of The Verge's Top 50 most important people at the intersection of technology, art, science, and culture.  Here is an excerpt from the piece: 

"His efforts have made the [fecal transplant] procedure — one that's surprisingly effective — far more accessible than ever before. Prior to 2013, when OpenBiome started the project, people suffering from a C. diffinfection had to try to find their own donors, and the stool sample had to be fresh. But Smith and his colleagues changed all that. He calls OpenBiome "Red Cross, but for poop," and it has the potential to turn poop into something truly life-saving."

Mark's profile can be found here and the full collection can be viewed here

The Excrement Experiment

In the December 1, 2014 issue of The New Yorker, editor Emily Eakin explores the proliferation of fecal transplants in the last few years, helped along by OpenBiome.  Here is an excerpt: 

"The inspiration for OpenBiome was a friend of Smith’s, an otherwise healthy man in his twenties who, in 2011, acquired C. difficile following gallbladder surgery. 'He ended up on seven rounds of vancomycin over a year and half,' Smith told me. 'He was very sick.' The man found a doctor who was open to the idea of performing a fecal transplant and waited six months while the doctor researched the procedure. Finally, unable to wait any longer, he gave himself a transplant using his roommate’s stool. 'It worked for him,' Smith, who was then completing his Ph.D., said. 'But the whole thing seemed very bizarre to me: why is it so hard to get a treatment that is very effective?'" 

Read the full story here

"OpenBiome remains open to serve the medical community"

Members of OpenBiome's leadership authored a Letter to the Editor of Nature Biotechnology in the September 2014 edition, correcting an article that gave the impression that FDA regulations had changed and OpenBiome was no longer in operation.  Here is an excerpt: 

"The article contained a box titled “Stool bank shut down,” indicating that OpenBiome would no longer be able to supply processed stool from rigorously screened anonymous donors for FMT. We would like to clarify that this is not the case. Current FDA guidance allows clinicians to provide FMT for patients with recurrent Clostridium difficile infection (CDI) using material either from patient-identified donors or from stool banks, such as OpenBiome. Indeed, as of July 10, OpenBiome has provided material for >600 treatments to 65 hospitals and clinics in 27 states."

Since publication, the number of treated patients has risen to more than 1000, across more than 100 partners in OpenBiome's clinical network. 

The full letter, which is behind a paywall, may be available to some readers here

"When feces is the best medicine"

Amanda Schaffer of The Atlantic took a deep look into OpenBiome and the policy questions facing regulators on how to advance safe access to fecal microbiota transplantation. The result is this terrific piece.  Schaffer writes: 

"[FMT] is about as close to a miracle cure as medicine offers. Yet access to fecal transplants has proven challenging. As recently as 2013, Amy Barto, a gastroenterologist at the Lahey Clinic in Massachusetts, said her patients had to find their own stool donors, whom the clinic would screen individually. On the day of the procedure, the donor had to provide a fresh stool sample, which Barto said she personally mixed using a blender from Target and transplanted into the patient’s colon. 'It was embarrassing and stressful for patients to find their own donors, and expensive to have them screened,' she said. 'I did about 100 procedures with the blender, and it was not efficient.'

'When OpenBiome was established, my quality of life went through the roof,' Barto said. More importantly, access to the procedure 'just blossomed.' More doctors were willing to get involved and patients were able to able to get the procedure more quickly, with fewer barriers and less expense."

Read the full piece here