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. 

TEDMED (VIDEO)

With the rise of antibiotic resistance, the search is on for therapies that can combat bacterial infections without engaging in an evolutionary arms race.

OpenBiome is a nonprofit stool bank that aims to expand safe access to fecal transplantation for patients with recurrent C. difficile 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 700 healthcare institutions across all 50 states and 6 countries to deliver over 14,000 treatments for recurrent C. difficile. Its portfolio includes 50% of all U.S. trials exploring the use of fecal transplants in new diseases. Watch the TED Talk here.

VICE on HBO (VIDEO)

For years, medical science was powerless against one of the most of severe intestinal infections. But a new treatment shows tremendous promise -- if patients aren't too squeamish to try it.

Fecal transplants use the stool from a healthy person to repopulate life-sustaining bacteria in the colon of the patient. This technique is so effective that researchers are testing its potential to treat disorders far beyond the digestive tract, pointing to breakthrough treatments for a broad range of the most stubborn diseases.

VICE reports from the labs and lavatories where this medical revolution is taking place. Watch the full video or the debrief.

Banking on stool despite an uncertain future

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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. 

The Demand for Poop

"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.”"

To Ease Fecal Treatment, Stool Bank Starts Producing Long-Awaited "Poop Pill"

"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.'"

 

There's a Huge Advancement in Poop Science That Could Save Thousands of Lives

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"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?'"

Save Your Microbiome for a Rainy Day

"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

Fecal Transplants Made (Somewhat) More Palatable

"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."

(Headlined "Waste As Its Own Solution" in the print edition.)

Should We Bank Our Own Stool?

"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 re-infuse patients with their own microbes after antibiotics?"

 

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

One Man's Poop is Another's Medicine [VIDEO]

Click to view on CNN.com

Click to view on CNN.com

In this video, CNN Health correspondent Elizabeth Cohen spends a morning with Eric, an OpenBiome donor, to capture the experience of what it takes to donate stool for medicine, and how his stool gets processed into treatments (featuring Lab Technician Christina Kim).  

Stool Bank May Be Answer to Recurrent Gut Infections

"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.'" 

 

 

Poop Transplants and Microbiome Makeovers

"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."

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

"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.  

Stool Transplants Save Lives. Why Don't We Use Them Early For Deadly C. Diff?

There is better efficacy data for FMT treatment than for many things that we do to our patients. Isn’t it time that we got over our juvenile squeamishness and offered our patients life-saving stool transplants initially, without cumbersome barriers? This treatment appears more efficacious and is almost certainly cost-effective as well. It’s time for widespread adaptation of this technique, including in those who are acutely ill.

Click here for the full article.

 

You Can Earn $13,000 A Year Selling Your Poop

"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."