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Yeah, you read it right and it's a serious subject. They can be used to treat a particularly nasty bowel infection caused by a bug named Clostridium difficile (abbr: C. difficile or C. diff), but getting the treatment approved for widespread use has met bureaucratic and regulatory hurdles....
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Fecal Transplants: They Work, the Regulations Don’t
Lara Thompson was 26 when her life fell apart.
She was living in Rhode Island and working in HIV prevention research when she unexpectedly developed nausea and diarrhea. It was early 2008, a few weeks after New Year’s, and she thought she might have picked up a stomach virus at a holiday gathering, or stressed her system with overindulgence. She expected the symptoms would pass after a few days. They didn’t.
“In three weeks, I dropped 15-20 pounds,†she says now. “I couldn’t keep anything in; I would have to run to the bathroom at a moment’s notice. I was so lethargic I had to stay home from work.â€
When she consulted her doctor, she found out what was bothering her was more complex than a virus. Somehow, her intestinal lining had become infected with Clostridium difficile, or C. diff, a tough and persistent bacterium that has been rising in incidence and gaining antibiotic resistance, becoming increasingly difficult to treat.
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For months, physicians kept trying different drug regimens, while Thompson’s hair fell out and her muscles wasted. By summer, she was down 40 pounds and close to desperate. Scouring the internet for alternatives, she found a description of a treatment that didn’t use drugs. It was a fecal transplant, which is just what it sounds like: inserting strained, diluted feces harvested from someone with a healthy gut into the sick person’s large intestine, in hopes of replacing the devastated colony of bacteria living there with a fresh, robust one.
“It made sense to me,†Thompson says now. “And I had no other options. I was getting sicker, basically living in the bathroom, crying, emotional all the time.â€
She gathered everything she could print out, and found a doctor who was friendly to the procedure: Colleen Kelly, a gastroenterologist based in Providence. In late October 2008, Kelly performed the transplant as an outpatient procedure, after Thompson had done the clean-out preparations that someone does to get ready for a colonoscopy. Her boyfriend was her donor.
In two hours, she started feeling better. In three years, her C. diff has never recurred.
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But, of course, there’s a problem:
So, to be clear, what we have is a treatment that is minimally invasive, reliable, cheap, and with a long clinical history: The earliest documented use in humans goes back to 1958, and it has a longer and still current use in veterinary medicine, especially in racehorses. Also, it works, in more than 9 out of 10 patients. Kelly told me: “There is no drug, for anything†with a cure rate routinely that high.
And yet, because of this regulatory conundrum, the only physicians practicing it are ones whose institutions are tolerant of their performing an unofficially experimental procedure, and who are strong-stomached enough to get past our evolutionarily hard-wired distaste for dung. So far, only about a dozen U.S. physicians have admitted — via publishing their case series in medical journals — to performing fecal transplants, though the procedure’s much more widely accepted in Australia and Europe.
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Lara Thompson was 26 when her life fell apart.
She was living in Rhode Island and working in HIV prevention research when she unexpectedly developed nausea and diarrhea. It was early 2008, a few weeks after New Year’s, and she thought she might have picked up a stomach virus at a holiday gathering, or stressed her system with overindulgence. She expected the symptoms would pass after a few days. They didn’t.
“In three weeks, I dropped 15-20 pounds,†she says now. “I couldn’t keep anything in; I would have to run to the bathroom at a moment’s notice. I was so lethargic I had to stay home from work.â€
When she consulted her doctor, she found out what was bothering her was more complex than a virus. Somehow, her intestinal lining had become infected with Clostridium difficile, or C. diff, a tough and persistent bacterium that has been rising in incidence and gaining antibiotic resistance, becoming increasingly difficult to treat.
>
For months, physicians kept trying different drug regimens, while Thompson’s hair fell out and her muscles wasted. By summer, she was down 40 pounds and close to desperate. Scouring the internet for alternatives, she found a description of a treatment that didn’t use drugs. It was a fecal transplant, which is just what it sounds like: inserting strained, diluted feces harvested from someone with a healthy gut into the sick person’s large intestine, in hopes of replacing the devastated colony of bacteria living there with a fresh, robust one.
“It made sense to me,†Thompson says now. “And I had no other options. I was getting sicker, basically living in the bathroom, crying, emotional all the time.â€
She gathered everything she could print out, and found a doctor who was friendly to the procedure: Colleen Kelly, a gastroenterologist based in Providence. In late October 2008, Kelly performed the transplant as an outpatient procedure, after Thompson had done the clean-out preparations that someone does to get ready for a colonoscopy. Her boyfriend was her donor.
In two hours, she started feeling better. In three years, her C. diff has never recurred.
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But, of course, there’s a problem:
… Fecal transplants remain a niche therapy, practiced only by gastroenterologists who work for broad-minded institutions and who have overcome the ick factor. To become widely accepted, recommended by professional societies and reimbursed by insurers, the transplants will need to be rigorously studied in a randomized clinical trial, in which people taking a treatment are assessed alongside people who are not.
Kelly and several others have drafted a trial design to submit to the National Institutes of Health for grant funding. Yet an unexpected obstacle stands in their way: before the NIH approves any trial, the substance being studied must be granted “investigational†status by the Food and Drug Administration. The main categories under which the FDA considers things to be investigated are drugs, devices, and biological products such as vaccines and tissues. Feces simply do not fit into any of those categories.
Kelly and several others have drafted a trial design to submit to the National Institutes of Health for grant funding. Yet an unexpected obstacle stands in their way: before the NIH approves any trial, the substance being studied must be granted “investigational†status by the Food and Drug Administration. The main categories under which the FDA considers things to be investigated are drugs, devices, and biological products such as vaccines and tissues. Feces simply do not fit into any of those categories.
And yet, because of this regulatory conundrum, the only physicians practicing it are ones whose institutions are tolerant of their performing an unofficially experimental procedure, and who are strong-stomached enough to get past our evolutionarily hard-wired distaste for dung. So far, only about a dozen U.S. physicians have admitted — via publishing their case series in medical journals — to performing fecal transplants, though the procedure’s much more widely accepted in Australia and Europe.
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