Fecal microbiota transplant promising for refractory ulcerative colitis

Last Updated: 2016-05-23

By Megan Brooks

NEW YORK (Reuters Health) - Fecal microbiota transplantation (FMT) -- a treatment currently used for recurrent Clostridium difficile infection -- may help patients with ulcerative colitis, a new study suggests.

In the study, one in four patients who were resistant or intolerant to conventional UC treatment (steroids and anti-inflammatory agents) reported that their symptoms subsided after FMT. And more than half reported symptom improvement with FMT. Signs of healing or significant improvement in the digestive tracts of these patients were evident on endoscopic examination.

Dr. Sudarshan Paramsothy, gastroenterologist at the University of New South Wales, Australia, reported the study findings May 23 in San Diego at Digestive Disease Week 2016.

"In recent years, researchers have gained a better understanding of the gut microbiota and the critical role it plays in health and disease, including conditions like ulcerative colitis," Dr. Paramsothy said in a conference statement. "By using fecal microbiota transplantation, we aim to treat the underlying cause of ulcerative colitis instead of just its symptoms, as opposed to the majority of therapies currently available."

The study included 81 patients with active UC resistant to standard non-biologic treatments. Forty-one received FMT and 40 received non-active placebo FMT. Patients received the first FMT and placebo treatment through a colonoscope. Thereafter, FMT and placebo were self-administered via enema five days a week for eight weeks.

In FMT, fecal matter is collected from healthy individuals who are screened to ensure that the stool is safe for transplantation. The stool is processed and transplanted via colonoscopy, endoscopy or enema. In this study, each FMT enema consisted of stool from at least three donors. This multi-donor method helps to ensure that the study results are not influenced by a "donor effect," in which individual patient outcomes may be unduly influenced by the microbial characteristics of a single donor, Dr. Paramsothy explained during a media briefing.

At the end of eight weeks, more than three times as many FMT patients than placebo patients responded to treatment. Eleven of 41 FMT patients (27%) achieved the study's primary goal: no patient-reported UC symptoms and healing or substantial improvement in lining of the digestive tract. Only three of the 40 patients (8%) in the placebo group achieved this goal.

When considering just the number of patients who said they were symptom-free (and not clinician observation of the colon), 44% of FMT patients reported improvement versus 20% in the placebo group.

"Overall more than half the patients experienced symptom improvement," Dr. Paramsothy said.

"Our study is the first multicenter trial that uses an intense therapy of FMT infusions, 40 over eight weeks, and has been able to show definitively that fecal microbiota transplantation is an effective treatment for ulcerative colitis," he added.

"This is important because there are millions of people worldwide seeking alternative treatments for their condition. This population is accustomed to using enemas as part of existing therapies, so our approach would not be unusual to them," he said.

Why FMT is helpful in UC remains unclear, he told the briefing. "We suspect that it has something to do with the microbial changes that occur in the recipient after receiving the FMT from the healthy donor and we are actually in the process of conducting microbiological studies on samples that have been collected during the trial to better ascertain this. At the moment, we don't clearly know what the underlying basis is for why some patients may respond and others don't," Dr. Paramsothy noted.

The long-term effects of FMT on UC symptoms also needs further study, he said. This trial only followed patients for eight weeks after cessation of FMT therapy.

SOURCE: http://bit.ly/1fHYpd8

DDW 2016.