2014

When feces is the best medicine

"[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."

FDA grapples with oversight of fecal transplants

"With so few providers available, proponents of stool transplantation have come up with innovative solutions. One big hurdle is the high cost of screening a stool sample, which can run up to $1,500 per sample. Insurance typically doesn't cover testing the stool sample because donors are usually healthy without signs of sickness.

Since October 2013, a Boston-based "stool bank" has managed to bring costs down to about $250 per treatment by screening samples in bulk. To date, OpenBiome has shipped over 300 stool samples in ready-to-use frozen preparations to 39 hospitals.

But in March, the FDA released an updated proposal for regulating fecal transplants, saying doctors should only use stool from a donor who is "known" to either the patient or their physician. Some doctors and patients worried the proposal, if finalized, would shutter OpenBiome and a handful of other stool banks, which use anonymous donors and ship to providers hundreds of miles away.

But OpenBiome founder, Mark Smith, says his group continues operating after having several productive discussions with the FDA. Smith says regulators have encouraged him to set up a formal study in which hospitals that work with OpenBiome will contribute data on the safety and effectiveness of fecal transplants."

Read the full story here on Fox or here on Businessweek. 

Medicine's Dirty Secret

"This is how far a mother will go.

Your daughter has been sick for more than four years with a severe autoimmune disease that has left her colon raw with bloody ulcers. After multiple doctors and drugs have failed, you are frantic for her to get better. Then you send her disease into remission, virtually overnight, with a single act of love. “Who wouldn’t do that for their daughter?” you say. It’s like a miracle, you say. “An overnight magic wand.”

You’ve agreed to do it again – twice – for strangers. You’ve seen first-hand how effective it can be and you felt so badly for the patients and their families. Had you donated blood or plasma, no one would blink. But this? You can’t tell anyone else about this because of how they might react.

There are more like you, men and women who have given their loved ones a remarkable reprieve from a group of chronic conditions known as inflammatory bowel disease. There are many more who have cured patients of a potentially fatal bacterium known as Clostridium difficile. This microbe can persist in a cocoon-like spore for up to five months, impervious to nearly everything except bleach. It is fast becoming resistant to every antibiotic thrown at it."

Read the full story here

MIT Lab Hosts Nation's First Stool Bank, But Will It Survive?

"You walk through a labyrinth of MIT buildings and into what looks like a typical laboratory: white walls and clean counters, the constant buzz of machines, the clutter of pipettes. In the corner, you open the door to a hulking freezer. When the puff of frosty air clears, you see stacks of plastic bottles filled with what looks a little like smoothies — in tawny, rusty colors Odwalla would never market. That’s your first hint of this lab’s unique purpose. Then there’s the giveaway: on the sterile countertop, you see a trophy of a squatting muscleman, labeled “Most Generous Donation.” Welcome to the first national stool bank. It’s like a blood bank, but for fecal matter. And that brown smoothie is actually very healthy stool, parasite-free and loaded with happy bacteria."

Here's the full piece. 

Alternatives needed to do-it-yourself feces swaps

"Already, instructions for home transplants are available online, with YouTube videos promoting the use of feces from friends and family. “Some have even approached us for advice about using their pets as donors,”  write microbiologist Mark Smith and bioengineer Eric Alm, both at MIT, and gastroenterologist Colleen Kelly of Brown University. Dog poop probably isn’t going to cure you of much, since dogs carry different bacteria than people do, and home procedures with pet or human stool can be dangerous, as I discussed previously. Not to mention that a home enema may not even get the microbes far enough into the digestive tract to be useful in many cases.

On the other hand, people are legitimately eager to treat their serious conditions with a method that has shown success rates of 90 percent and better in published trials treating C. difficile, a bacterium that causes severe diarrhea."

Here's the full piece.

Cambridge stool bank helps meet growing need for fecal transplants

A new post by Carolyn Johnson in the Science in Mind section of Boston.com describes the proposal put forth by OpenBiome co-founder Mark Smith, Dr. Colleen Kelly, and Professor Eric J. Alm in Nature that stool for fecal transplants should be regulated not as a drug but similarly to tissue or blood.  Here is an excerpt:

"A group of researchers from the Massachusetts Institute of Technology and the Alpert Medical School of Brown University proposed Wednesday that fecal transplants be regulated similarly to tissue or blood.

In fecal transplants, a slurry of feces containing the gut bacteria from a healthy donor are implanted into the intestine, either through a nasal tube or a procedure similar to a colonoscopy. Official guidelines about how to screen donors and ensure samples are safe will help bring clarity and uniformity to a field that has become something of a Wild West. Researchers are concerned because YouTube videos now offer guidance on DIY fecal transplants for at-home use, and misinformation is abundant. The team that wrote the study has received questions from people suffering from gastrointestinal infections who wonder whether their pets could be used as donors. (They cannot.)"

The full text is here

Policy: How to regulate faecal transplants

Today in Nature,  a new comment by Mark B. Smith, Colleen Kelly, and Eric J. Alm makes the case that stool used in medical practice should be regulated like tissue or blood, and not like a drug, as current regulations dictate.  The piece highlights the role for stool banks like OpenBiome in facilitating safe access to material, to avoid circumstances in which patients, with no other alternatives, try to perform fecal transplants themselves.  Here's an excerpt: 

"[The first randomized controlled trial investigating the medical use of human feces] was stopped ahead of schedule because the faecal slurry was more than twice as effective in resolving symptoms as antibiotics alone1. Non-randomized studies, with outcomes collected from hundreds of people suffering from recurrent C. difficile infections and treated with similar procedures, have had typical success rates of around 90% (ref. 2).

First described3 in the scientific literature in 1958, faecal microbiota transplantation (FMT), delivers processed stool from a healthy individual to the gut of a sick person through enema, colonoscopy or other means. The goal is to displace pathogenic microbes from the intestine by re-establishing a healthy microbial community. Interest has surged in the past five years (see 'Stool treatment'). At the same time, new regulatory barriers have made FMT more difficult to study or practice."

Mark is a co-founder of OpenBiome and PhD candidate in microbiology at MIT, Dr. Colleen Kelly is a gastroenterologist and clinical assistant professor of medicine at the Alpert Medical School at Brown University, and Dr. Eric Alm is an associate professor of biological engineering at MIT and OpenBiome team member. 

Read the full piece here

A New Kind of Transplant Bank

"Around noon on a recent Friday, Donor Five, a healthy 31-year-old, walked across M.I.T.’s frigid, wind-swept campus to a third-floor restroom to make a contribution to public health.

Less than two hours later, a technician blended the donor’s stool into preparations that looked like chocolate milk. The material was separated and stored in freezers at an M.I.T. microbiology lab, awaiting shipment to hospitals around the country. Each container was carefully labeled: Fecal Microbiota Preparation."

Read the full piece here

Need a fecal transplant? There's a poop bank for that

"As we increasingly realize the role of the microbiota in just about every aspect of human health, the idea of banking healthy gut microbiota through poop doesn't seem very outlandish. (Note: While there are many associations between differences in the gut microbiota and certain diseases such as obesity and asthma, there's less evidence, at least for the time being, that a fecal transplant can cure diseases aside from C. difficile.) The "Brown Cross" could become part of our public health infrastructure."

Read the full post here

Introducing the first bank of feces

Erika Engelhaupt, an editor at Science News and writer for the magazine's Gory Details blog, provides a synopsis of OpenBiome in a post on February 12.  The following line captures the piece:

"A new nonprofit called OpenBiome is hoping to do for fecal transplants what blood banks have done for transfusions. It’s a kind of Brown Cross."

We loved the new moniker!  In her piece, Erika also suggests that stool banks could provide an important alternative to the risky practice of at-home treatments. The full post is here

The Chronicle of Higher Education covers OpenBiome

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David Glenn from The Chronicle of Higher Education featured OpenBiome in the story, "Student-Led Project Banks on Promise of Fecal Transplants" on February 3rd.  The full article is behind a paywall, but here is an excerpt:

"By the end of the weekend, the two graduate students [Carolyn Edelstein and Mark Smith] and James Burgess—another friend from their Princeton days—had hatched a plan. They would open the world’s first public stool bank, offering prescreened, frozen fecal specimens to hospitals around the country. What the Red Cross has done for blood, their project—known as OpenBiome—would do for feces."

The full text is available here to Chronicle subscribers.