Why DIY fecal transplants are a thing (and the FDA is only part of the reason) | Public Health

Michael K. was three days away from surgery to remove part of his intestine (the last-resort treatment for his ulcerative colitis) when he heard about a treatment his doctor had never recommended: fecal transplants. He canceled the surgery, sought help from a mentor, and chose a friend who he thought would be a good source of healthy donor material. What happened next sounds a bit like an oddball marriage proposal: he took the friend on a hike, made a few poop jokes, and then popped the question.

The friend said yes, as he writes in his success story on The Power of Poo, a website created to help patients find help with fecal transplants (DIY or otherwise.) The two moved in together for more convenient poop swapping, since he wanted to do the transplants frequently, and they need to be fresh.

If you want something done, you’ve got to do it yourself?

Is the age of the do-it-yourself fecal transplant upon us? That was several experts’ concern after the FDA’s recent decision to regulate fecal transplants as an investigational new drug. (Judy Stone‘s is one take worth reading) As a result, the treatment, which was on a trajectory toward mainstream acceptance, will once again–temporarily–be rare and hard to get in the US.

Fecal matter occupied a gray area, neither drug nor device nor tissue, when Maryn McKenna reported two years ago that “fecal transplants work, but the regulations don’t.” At the time, several researchers were applying to begin clinical trials. That would be the road toward getting the transplants, known as FMT (for “fecal microbiota therapy”, although there are a lot of other names: stool transplant, fecal bacteriotherapy, human probiotic infusion…) approved and widely available. Now, FMTs are considered to be in Phase 1 of a three-phase process.

In the meantime, doctors operated within the gray area and tried it out. It worked, they shared results, and soon FMT got its own billing code (44705) and a set of guidelines that include a battery of tests for donors: blood tests for diseases like HIV, and stool screening for parasites and the like. The price of donor testing is estimated at anywhere from $500 to $1500+, depending on who’s doing the estimating and what tests they include. Good luck getting insurance to cover it.

If you have the cash, though, FMT is worth it. The studies that have been done so far are astounding: in one trial of patients suffering from C. difficile infection (a diarrheal disease that can be life-threatening and antibiotic-resistant), an infusion of feces cured 94% of the patients. The usual treatment, an antibiotic called vancomycin, only cured 27%. The trial was stopped early because the difference was so drastic; it was unethical to keep half the patients on antibiotics alone when a better treatment was available. Gastroenterologists agree: FMT is not just effective for C. diff, it’s extremely safe. The American College of Gastroenterology writes in their C. difficile treatment guidelines that “no adverse effects or complications directly attributable to the procedure have yet been described in the literature.”

Dr. Michael Edmond, who used to offer the procedure, blogged recently about canceling patients’ appointments and applying for the Investigational New Drug permit that is now required. (The FDA will approve or deny the application within 30 days, but won’t tell him the criteria they use to decide.) He told The Verge: “by trying to make fecal transplants safer, the FDA is actually pushing them underground.”

The underground

They have been underground for a while, of course. Only a few clinics offer the treatment, and some (like the Centre for Digestive Diseases in Australia) give patients instructions on doing the procedure at home. Meanwhile, sufferers of inflammatory bowel disorders are already sharing tips and support online, so DIY instructions fit right in. If you are desperate and willing to try anything, Dr. Google and Dr. Facebook are there for you.

The gross-out factor probably contributes to the scarcity of medical professionals offering the treatment. Tracy Mac, who runs the Power of Poo website, describes her gastroenterologist’s reaction when she suggested a fecal transplant: “He screwed up his nose like a seven-year old and observed ‘but it’s putting someone else’s poooo inside of you’. An interesting comment coming from someone who makes a living sticking cameras up bums!”

The thing is, if you have Crohn’s, C. diff, or ulcerative colitis, fecal transplants mean dealing with less poop, less often. “[I] realize that doing the fecal enemas is not that bad,” Michael writes. “Afterall the illness caused me to poop my pants with bloody diarrhea at times.”

Also spurring the do-it-yourself phenomenon: those amazing results I mentioned earlier are from C. diff infections, but many patients seeking the treatment have ulcerative colitis, Crohn’s, or sometimes other disorders. The evidence is less definitive on those, although still promising. It may be the nature of the disease: If you have C. diff, your problem can be traced back to a single misbehaving species of bacteria.

This one.

For inflammatory bowel disorders, the disease and its causes may be more complex. Tracy Mac attributes mental health problems to an unhappy gut, which is not as far-fetched as it may sound: a recent study found that gut microbes can influence brain function in humans. Scientists in the Netherlands are testing fecal transplants for weight loss and insulin resistance. The gut microbiome seems to be a key player in health and disease, so FMTs have a lot of potential. Potentially.

How it’s done

While C. diff treatment often uses one transplant or a short series, sufferers of inflammatory bowel diseases like ulcerative colitis and Crohn’s often prefer a long term strategy. Kathy explains why she has been doing FMTs for her daughter for the better part of a year: she was in a trial testing fecal transplants for ulcerative colitis, and did so well that they decided to continue at home. “We have kept up the FMT because we believe the intestines take a long time to heal, and because we don’t think it can hurt,” she writes. “While we have faith in the treatment, we don’t want to stop it yet, either.”

Kathy has a fascinating, simple, instructive video on youtube. Neatly dressed–and still spotless at the end–she prepares a sample in her bathroom, as she does several times a week. She has a dedicated blender, cup, strainer, and spoon, and she wears gloves. Ten minutes for prep, she says, five minutes for cleanup, and about thirty seconds to administer. Afterward, she used to ask her daughter to lie down and watch a movie; after nine months of treatment, she’s as likely to do a handstand for a few minutes and then go about her day.

In a hospital setting, the transplant is often performed with colonoscopy equipment, to infuse the sample as far back in the colon as possible. It’s also possible to run a tube from the patient’s nose down past their stomach. For the do-it-yourselfers, the more accessible option is to simply use an enema bottle. (The smaller size, I keep hearing: a little goes a long way.) In fact, there is research suggesting that enemas may be the most effective delivery method, but there’s just not enough data yet to say for sure.

What? Sometimes a glass of chocolate milk is just a glass of chocolate milk. Photo by mynameisharsha.

What now?

There are lots and lots of questions about fecal transplants. We’re just coming to grips with the gut microbiome’s impact on health and disease, and we know so little about what is actually in that magical brown pellet (which is about 55% bacteria, in case you were wondering.) Does a donor have to be matched to the patient, or is any healthy stool good enough? Do some patients respond to the treatment and others don’t – maybe in a predictable way? Does the sample need to be fresh, and if not, what is the best way to store it? Can poop be replaced entirely by a synthetic, probiotic concoction? Are there legions of failed FMT patients who are too disappointed, or embarrassed, to publish negative results?

I’m looking forward to hearing the answers to those questions, and I hope the FDA’s rules don’t keep life-saving treatment from those who need it (They have promised emergency approvals in dire situations). In the meantime, if you want to hear about the current state of the science from those on the front lines, the transcripts from the recent FDA workshop will make excellent reading on the beach this summer. All summer. We’re talking 600+ pages. Enjoy?

(Update: I’ve corrected this piece to refer to inflammatory bowel diseases, or IBD, an umbrella term for diseases including Crohn’s and ulcerative colitis. That’s distinct from irritable bowel syndrome, which is what I originally wrote. Not the same thing! Thanks to Tracy for setting me straight.)

The Why DIY fecal transplants are a thing (and the FDA is only part of the reason) by Public Health, unless otherwise expressly stated, is licensed under a Creative Commons Attribution 3.0 Unported License.