A nose-wrinkling procedure to use human feces to treat a serious gut infection gained worldwide attention a year ago, when a top medical journal published a study showing just how effective it was when compared to routine antibiotic treatment. In the meantime, regulators have been wrestling with what sort of oversight should be used on this scatological treatment.
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 strained and implanted into the intestine. 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 do-it-yourself 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 excitement about the successful use of fecal transplants to treat the gastrointestinal infection C. difficile has also led to a premature interest among the general public suffering from ailments for which it is completely unproven and untested.
“I have pretty serious concerns about this,” said Mark Smith, a graduate student in microbiology at MIT who co-wrote the paper published in Nature. “It’s an exciting area of research, but it’s not ready for every patient to get their hands on.”
In Cambridge, Smith has cofounded a nonprofit stool bank called OpenBiome that carefully prepares feces samples for doctors to use in treating C. difficile. The stool bank has already sent out more than 130 samples for transplant into patients, for $250 per treatment.
OpenBiome is pioneering a model that may be able to create a steady supply, by taking a page from nonprofit blood banks. So far, there are three active donors providing samples to OpenBiome, with more awaiting clearance of screening tests. The donors are rigorously tested before and after a 60-day collection period, and the samples are quarantined until those tests come back clean.
Donors drop by the laboratory to make two to three deposits a week into the stool bank, Smith said. They are researchers from the broader Harvard and MIT community, and are paid $40 per donation. Smith even created an informal competition among the donors to see who could make the most generous contribution. The trophy — a squatting wrestler — initially went to a person who provided a sample that could be used to treat 10 people.
Smith said that developing the stool bank is far from what he imagined he would be doing when he started graduate school, but that his main motivation is understanding the science behind the remarkable treatment. He is working to enroll some of the patients who receive the samples in a research study so that scientists can begin to discern which bacterial strains are the key ones that are repopulating their guts. That information could help guide the development of a synthetic treatment — one that could easily be regulated as a drug.