The study results were presented at the European Crohn’s and Colitis Organization 2016 Congress.
The research is important because it’s the largest and most intensive trial of fecal transplants to treat ulcerative colitis, says Sudarshan Paramsothy, MD, from the University of New South Wales in Kensington, Australia.
In the study, 41 adults received a fecal transplant by colonoscopy, then followed up with five active fecal transplant enemas each week for 8 weeks, done at home. Another 40 received a placebo treatment. During a study extension, though, 37 people in the placebo group chose to switch and receive fecal transplants.
Each 150 milliliters of fecal material contained previously frozen stool from three to seven unrelated donors.
"We used this multi-donor concept for logistical reasons because of the number of infusions required for this trial," Paramsothy says. The research team also wanted to prevent patients from receiving an infusion transplant from a single bad donor. All patients in the study had active mild-to-moderate ulcerative colitis and phased out the use of steroid treatment during the study period.
Of the 41 patients receiving fecal transplants, 44% were considered to be in remission without steroids. That means they had no rectal bleeding or diarrhea. Only 20% of the placebo group achieved remission.
Study participants told the researchers they had belly pain and flatulence, Paramsothy says. Three people had serious complications in the first 8 weeks -- colitis worsened in two people in the fecal transplant group (one needed surgery to remove the colon) and one in the placebo group.
Key Questions Remain
"We have considerable safety questions," said session moderator Philippe Seksik, MD, PhD, from Hôpital Saint-Antoine in Paris.
With a single transplant donor, he says, there is a lower risk of spreading something unwanted. Ideally, he says, multi-donor samples would be frozen for months while donors are checked for any health issues.
The FDA just announced it intends to increase the regulation of fecal transplants to promote greater safety and availability for patients. The procedure is cleared only for the treatment of Clostridium difficileinfection for now.
Multi-donor transplantations "are another piece of the puzzle,” says Ailsa Hart, PhD, from St. Mark’s Hospital in London. “There are quite a number of studies on this underway now. It looks exciting, but we need more study.”
Dr. Paramsothy reports receiving grants from Abbott/GESA IBD Clinical Research, the Broad Medical Research Program, the Sunshine Coast Wishlist Research Grant Scheme, the UNSW Gold Star Award, and the National Health and Medical Research Council Medical Postgraduate Research Scholarship. Dr. Seksik and Dr. Hart have disclosed no relevant financial relationships.