Health Canada has issued new guidelines that will allow the use of fecal transplants outside of clinical trials in some conditions, opening the door to more widespread use of a procedure inaccessible enough that some people are seeking do-it-yourself tutorials online.
Up until the new guidance document was released Friday, Health Canada had taken the position that fecal therapy was an investigational procedure that could only be conducted in authorized clinical trials. But some doctors argued the therapy – which involves putting a healthy person's stool into a sick person's gut through an enema, colonoscopy or other means – should be more readily available, especially for patients with recurrent C. difficile.
In its updated guidance, Health Canada says "current evidence supports the safety and efficacy of using FMT [fecal microbiota therapy] to treat patients who have C. difficile that has been unresponsive to conventional therapies."
The revised guidelines apply only to using fecal transplants to treat C. difficile and is "an interim measure while Health Canada establishes a more appropriate long-term regulatory approach for FMT," the guidance states.
Currently, the main weapons to fight C. difficile infections are antibiotic drugs.
"It looks as though they are allowing fecal transplants for exactly the situation we were proposing: patients with C. difficile infections not responding to conventional treatment," Jeanne Keegan-Henry, a Burnaby physician, said Sunday in an e-mail.
Dr. Keegan-Henry was involved with a proposed pilot project at B.C.'s Fraser Health Authority that would have provided fecal transplants at two Lower Mainland sites. Fraser Health put the pilot project on hold last year because of Health Canada's position that FMT had to be conducted in authorized clinical trials.
"This will certainly save lives," Dr. Keegan-Henry said of the new guidelines. "Also – and this is a much more difficult thing to measure – it will prevent a huge amount of suffering and disability. And it will save money."
Clostridium difficile is a bacteria that can cause infection, most often in people who have been taking antibiotics that kill healthy gut bacteria and allow C. difficile to take hold. Infections result in diarrhea and can be fatal. Up to 25 per cent of people who have had a C. difficile infection and are treated for it will get sick again and the risk of re-infection increases after a relapse. C. difficile is the most frequent cause of infectious diarrhea in hospitals and long-term care facilities in Canada; the annual economic burden, including hospital costs, associated with the disease has been estimated as up to $281-million.
In recent years, anecdotal reports and some research has suggested fecal transplants are more effective than antibiotics in treating C. difficile.
Those glowing reports have also been a cause for concern. In a position paper last year, the Canadian Association of Gastroenterology said "the application of this [FMT] treatment is still in its infancy and long-term safety is not yet established." The group did, however, say FMT "is a viable option in patients who experience a [C. difficile infection] relapse after two courses of antibiotics."
Health Canada's guidance includes several conditions, including informed consent from patients and donor screening for transmissible diseases including HIV and hepatitis.
Fraser Health will review the new guidance to determine what it means for its pilot, spokeswoman Tasleem Juma said on Friday.
Health Canada's revised guidance is a "great idea" that puts Canada more in line with the United States, which adopted a similar approach to FMT oversight last year, said Theodore Steiner, a researcher with Vancouver Coastal Health Research Institute who has been studying C. difficile since 1995 and is involved in a multisite clinical trial of fecal therapy.
But he also has reservations, including concerns that some patients might seek fecal transplants for conditions other than recurrent C. difficile and that there are unknowns about the procedure and how it works.
"I think once people start doing the procedure more often, they'll find out it is more complicated than they think," Dr. Steiner said. "It's not as straightforward as it sounds."