Fecal transplant, an investigative therapy for inflammatory bowl disease (IBD), has recently been tested in its first randomized clinical trial. Treatment was effective in enough patients for researchers to consider this a promising therapy. These results were presented at Digestive Disease Week (DDW) 2014, May 3–6, in Chicago.[1]

Inflammatory bowl diseases include ulcerative colitis (UC), which involves the colon, and Crohn’s disease, which involves the entire gastrointestinal (GI) tract. With IBD the lining of the GI tract becomes inflamed, which can lead to ulcers and bleeding and symptoms including diarrhea,abdominal pain, and infections.

Fecal transplant, also known as fecal microbiota transplantation (FMT), has been used to treat overgrowth of bad bacteria in the digestive system, a condition known as Clostridium difficile (C diff). To perform FMT, stool from a healthy person is transferred to a person suffering from C diff whose condition has not improved with standard treatment; transplant is performed during colonoscopy or with a fecal enema. The goal is that good bacteria from the transplanted stool will grow in the patient’s colon and restore a healthy balance.

To investigate whether FMT could help relieve symptoms of IBD, researchers with McMaster University in Canada studied almost 60 patients with mild to moderate FMT. Participants were randomly assigned to one of two treatments: approximately half were given an FMT enema one time per week for six weeks, while the remaining half were give a placebo (inactive substitute) enema on the same schedule (one time per week for six weeks).

Though four of the patients who received FMT (15%) experienced clinical remission from IBD (no or very few symptoms), two patients who received placebo (8%) also experienced clinical remission. The results were close enough between the FMT and placebo group that they couldn’t be considered what’s known in clinical research as statistically significant. In other words, there wasn’t a large enough difference in outcome to indicate that the results couldn’t have occurred by chance alone; this trial didn’t prove that FMT was clinically effective therapy for IBD.

Researchers speculate, however, that FMT may be effective when administered over a longer period than the six-week duration of this trial. Several study participants (16 patients) who didn’t experience enough symptom relief to be considered in clinical remission during the first six weeks continued treatment with FMT for an additional six weeks to 12 weeks, at which point a portion (five patients) did experience clinical remission.

Additional studies have suggested that FMT may be a viable therapy for IBD. For example, results also presented at DDW 2014 indicated that a single FMT infusion administered during colonoscopy had therapeutic potential. With only seven patients, the study was small, but one participant did experience temporary relief, and all showed some measureable improvement at one month.[2] Other findings presented at DDW 2014 showed that FMT might also have some therapeutic activity in Crohn’s disease, including a study in which five of eight participants experienced clinical remission.[3]

Overall, FMT appeared safe in studies presented at DDW 2014. And though outcomes were mixed, the therapy did show signs of improving symptoms in some patients, which gives researchers enough encouraging evidence to continue studying FMT as treatment for IBD.

References:

[1] Moayyedi P, et al. A Randomized, Placebo-Controlled Trial of Fecal Microbiota Therapy in Active Ulceraive Colitis. DDW 2014; Abstract 929c.

[2] Libertucci J, et al. Investigating the Microbiome Pre- and Postfecal Microbiota Therapy from Active Ulcerative Colitis Patients in a Randomized Placebo-Controlled Trial. DDW 2014; Abstract Tu2033.

[3] Vaughn BP, et al. Fecal Microbiota Transplantation Induces Early Improvement in Symptoms in Patients With Active Crohn’s Disease. DDW 2014; Abstract Mo1228.

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