Background and Objective: Colonic dysbiosis contributes to the development of colonic inflammation in ulcerative colitis (UC). Fecal microbial transplantation (FMT) is being proposed as a novel treatment for UC because it can eliminate dysbiosis; however, no prospective data exist. We initiated a pilot study to evaluate feasibility and safety of FMT in children with UC.
Methods: Ten children, 7 to 21 years of age, with mild-to-moderate UC (pediatric UC activity index [PUCAI] between 15 and 65) received freshly prepared fecal enemas daily for 5 days. Data on tolerability, adverse events, and disease activity were collected during FMT and weekly for 4 weeks after FMT. Clinical response was defined as decrease in PUCAI by >15, and decrease in PUCAI to <10 was considered clinical remission.
Results: No serious adverse events were noted. Mild (cramping, fullness, flatulence, bloating, diarrhea, and blood in stool) to moderate (fever) adverse events were self-limiting. One subject could not retain fecal enemas. Average tolerated enema volume by remaining 9 subjects was 165 mL/day. After FMT, 7 of the 9 (78%) subjects showed clinical response within 1 week, 6 of the 9 (67%) subjects maintained clinical response at 1 month, and 3 of the 9 (33%) subjects achieved clinical remission at 1 week after FMT. Median PUCAI significantly improved after FMT (P = 0.03) compared with the baseline.
Conclusions: Fecal enemas were feasible and tolerated by children with UC. Adverse events were acceptable, self-limiting, and manageable by subjects. FMT indicated efficacy in the treatment of UC.
*Spectrum Health, Helen DeVos Children's Hospital, Grand Rapids
†Michigan State University, Grand Rapids, MI
‡Emory University School of Medicine, Atlanta, GA.
Address correspondence and reprint requests to Sachin Kunde, MD, MPH, Pediatric Gastroenterology, 35 Michigan St NE, Ste 4150, Grand Rapids, MI 49503 (e-mail: Sachin.Kunde@helendevoschildrens.org).
Received 5 March, 2013
Accepted 18 March, 2013
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www.clinicaltrials.gov registration number: NCT01560819.
The study was funded by a Helen DeVos Children's Hospital Foundation Grant.
The authors report no conflicts of interest.