The results of a trial presented at a meeting this week show that 1 in 4 patients with ulcerative colitis found their symptoms disappeared and their gut linings had healed or substantially improved after receiving fecal microbiota transplantation - without the use of steroids.
The findings feature at Digestive Disease Week 2016, San Diego, CA, 21-24 May, 2016.
Ulcerative colitis is a chronic inflammatory bowel disease (IBD) with no known cure. It arises from a recurring immune response that causes the colon or large intestine to become inflamed and ulcerated.
Ulcerative colitis affects millions of people around the world. The Centers for Disease Control and Prevention (CDC) estimate that around 238 out of every 100,000 adults in the United States have the condition.
Although the causes of ulcerative colitis are not well understood, there is evidence that gut bacteria or microbiota may play an important role.
Fecal microbiota transplantation (FMT) involves giving fecal material containing gut microbiota from a healthy person to a patient with a condition related to an imbalance of gut microbiota. The material is screened, processed, prepared, and given to the patient via colonoscopy, endoscopy, or enema.
Restoring gut microbiota to that of a healthy person
The goal of FMT is to treat the patient's condition by restoring their gut microbiota to that more typical of a healthy person.
There has been keen interest in FMT following reports of its use in the treatment of patients with Clostridium difficile infection.
For the trial, researchers in Australia - including Dr. Sudarshan Paramsothy, a gastroenterologist from the University of New South Wales - recruited 81 patients with ulcerative colitis from three different study sites.
The team randomly assigned the patients to receive either FMT treatment (41 subjects) or placebo (40 subjects). All patients had failed to respond to standard non-biologic treatments.
The participants received the first FMT and placebo through a colonoscope. After that, they gave themselves enemas 5 days per week for 8 weeks.
Symptoms cleared, colons healed in a quarter of patients
- Ulcerative colitis is slightly more common in men than women
- Each year in the U.S., around 2.2-14.3 cases of ulcerative colitis are diagnosed per 100,000 people
- The condition appears to be more prevalent in non-manual (white collar) occupations.
The results show that 11 of the 41 (27 percent) FMT patients achieved the study's two main goals: they reported their symptoms had gone away, and their digestive tract showed signs of having healed or improved (as evidenced via endoscopic examination). Both improvements were achieved without the use of steroids, note the researchers.
In contrast, only three of the 40 (8 percent) patients treated with placebo reached these two goals.
Dr. Paramsothy explains why their study is significant:
"Our study is the first multi-centered trial that uses an intense therapy of FMT infusions, 40 over 8 weeks, and has been able to show definitively that fecal microbiota transplantation is an effective treatment for ulcerative colitis."
He says previous studies using FMT to treat ulcerative colitis have been limited to small case series and two single-center trials and have produced conflicting results.
Another important feature of the study is that each FMT that the patients received contained fecal material from at least three donors.
This was to avoid the possibility of a "donor effect," where individual patient results might be unduly influenced by the gut microbes of a single donor.
"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."
Dr. Sudarshan Paramsothy
Meanwhile, experts are expressing concerns regarding FMT, particularly in relation to long-term effects. There is, for example, a theoretical possibility that infectious agents could be transmitted, or conditions and diseases could develop from changes in the gut microbiota.
There is evidence that human FMT from obese people to rodents may promote obesity, and FMT from lean people to obese recipients with metabolic syndrome has led to increased insulin sensitivity, say the authors of a review of FMT, who note:
"Clinical follow-up of patients over many years, ideally combined with analysis of banked donor and recipient specimens, will be crucial in assessing the possibility that FMT may increase (or decrease) the risk of a number of common chronic conditions."