LAST year wasn't kind to 27-year-old Jim. He was diagnosed with ulcerative colitis and it was causing him a lot of pain. Drugs failed to provide relief, and it seemed as if the only option was to surgically remove his colon. Instead, he opted for something else. Two weeks after having filtered faeces inserted into his guts, Jim improved massively. "The blood and pain are reduced, and I'm not having to worry about going to the toilet."
Jim is one of a growing number of people turning to faecal microbiota transplantation (FMT) to restore their gut bacteria to a healthy state. The idea is to reset the gut flora using bacteria in the stools of a healthy person.
Jim lives in the UK, where this procedure is not regulated so he was able to find a clinic to do it for him. In the US and Canada, however, the rules are stricter, and some people are taking the matter into their own hands. "People are turning to faecal transplants without any medical supervision. They don't even get the donor screened," says Emma Allen-Vercoe, a microbiologist at the University of Guelph in Ontario, Canada. "They're putting themselves at significant risk."
Last week, a group of microbiologists writing in Nature called for the US Food and Drug Administration to change the rules on FMT, and for regulators around the world to work out how to deal with the procedure. So how should such transplants be regulated? And is it worrying that people are doing it themselves?
The technique has shown most promise for treating people infected with Clostridium difficile, a bacterium that colonises people's gut when antibiotics have obliterated the other inhabitants, sometimes to fatal effect. The results of a clinical trial using FMT to treat people with recurring C. difficile infections, the first ever for any FMT treatment, were published last year. Fifteen out of 16 people given transplants were cured of their infections, compared with 4 of 13 patients receiving standard antibiotics.
Several case reports suggest that FMT can also relieve inflammatory bowel disease, including Crohn's disease and ulcerative colitis, and a few reports suggest possible benefits for people with autoimmune disorders and Parkinson's, but clinical trials have yet to be done.
As a result, the FDA considers FMT as an investigational drug for everything apart from treatment of non-responsive C. difficile. This means doctors have to apply for a licence to use the treatment as part of a study. The situation is similar in Canada. "It takes hundreds of hours to open an application and many more are spent monitoring patients," says Mark Smith at the Massachusetts Institute of Technology.
This means people are doing their own transplants at home, using little more than stools from a relative, a blender and an enema kit (see "From trash to treasure"). "People are making this in their basement," says Smith.
A quick online search offers up how-to guides and success stories, not just for gastrointestinal disorders, but for other conditions, for which evidence of FMT efficacy is even more scant. Some parents of children with severe autism, for example, are swapping notes on FMT on online forums, even though all they have to go on is limited evidence of an altered gut flora in autism, and a study that showed a species of bacteria could reverse some symptoms in mice with an autism-like disorder. "It worries me," says Allen-Vercoe. "This is a paediatric population. We have a duty of care here which is beyond that of adult patients."
Even in adults, inserting faeces into the gut is not without risk – there is a chance of introducing disease-causing bacteria and parasites, for example. Side effects have been rare so far, but there are reports of faecal transplants causing infection and gastrointestinal bleeding.
Microbiologists are just starting to understand the roles of the various bacteria that line our gut. Some types have been linked to diseases including cancer, obesity and diabetes – and there is no way to be sure the recipient of FMT isn't increasing their risk of these disorders, says Allen-Vercoe. "We shouldn't blithely be doing faecal transplants wherever we can just because we think it's a good idea," she says. "Nobody is monitoring what's happening long term."
But if people are going to take a DIY approach, might it not be safer to provide people, or their doctors, with safe samples?
Last year, Smith co-founded OpenBiome – a non-profit company in Cambridge, Massachusetts, that provides pre-screened, frozen faecal samples from healthy donors. At the moment, it offers samples only to doctors treating people with C. difficile infections – so it is of no use to people trying FMT at home. "It's really challenging, ethically," says Smith. "If a patient is dead set on getting treatment, it's probably a good idea to have a doctor help."
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