Intensive Fecal Microbiota Transplantation for Ulcerative Colitis

Summary and Comment |
February 23, 2017

Intensive Fecal Microbiota Transplantation for Ulcerative Colitis

  1. Douglas K. Rex, MD

Multidonor FMT via enema 5 to 7 days per week was superior to placebo for clinical remission and endoscopic response at 8 weeks.

  1. Douglas K. Rex, MD

Fecal microbiota transplantation (FMT) has been proposed for the treatment of ulcerative colitis. Of the two randomized, controlled trials of single-donor FMT (at a maximum once-weekly frequency) that have been performed in patients with ulcerative colitis, one study showed a possible improved outcome.

In the current double-blind study, researchers utilized a protocol of intensive FMT from multiple donors, randomizing 85 patients to FMT or placebo delivered via an initial colonoscopy and then by enema on at least 5 out of 7 days per week for 8 consecutive weeks. At least 3 to 7 individual donors contributed to each batch of FMT material. Participants were allowed to be on medications other than enema therapy prior to the trial if their doses were stable.

The primary outcome of steroid-free clinical remission and endoscopic remission or response at week 8, as defined by Mayo scores, was significantly higher with FMT versus placebo (27% vs. 8%). Steroid-free clinical remission was significantly higher (44% vs. 20%), as were steroid-free clinical response (54% vs. 23%) and steroid-free endoscopic response (32% vs. 10%) but not full endoscopic remission (12% and 8%; P=0.48).

Comment

The overall response rates for FMT in ulcerative colitis seem low in this study, but the number needed to treat for steroid-free clinical remission is only 4, which is similar to the number needed to treat for steroid-free endoscopic response. This could become a landmark study if it paves the way for multidonor FMT to become a mainstay of therapy for ulcerative colitis.

Editor Disclosures at Time of Publication

  • Disclosures for Douglas K. Rex, MD at time of publication Consultant / Advisory board Covidien; Olympus Corporation America; Endo-Aid Ltd.; Endochoice; Boston Scientific; Paion AG; Ironwood Pharmaceuticals; Colonary Solutions; Novo Nordisk Inc.; Medscape Gastroenterology Grant / Research support: Braintree Laboratories Editorial boards World Journal of Gastroenterology; The Journal of Clinical Gastroenterology; Techniques in Gastrointestinal Endoscopy; Gastroenterology & Hepatology; Expert Review of Gastroenterology & Hepatology; Medscape Gastroenterology; World Journal of Gastrointestinal Pharmacology and Therapeutics; Annals of Gastroenterology & Hepatology; World Journal of Gastrointestinal Oncology; Comparative Effectiveness Research; Journal of Anesthesia & Clinical Research; Gastroenterology; World Journal of Gastrointestinal Pathophysiology; Gastroenterology Research and Practice; GI & Hepatology News; Gastroenterology Report; Clinical Epidemiology Reviews; JSM Gastroenterology and Hepatology (associate editor); GI Journal Watch; Austin Journal of Gastroenterology; World Journal of Gastrointestinal Pharmacology & Therapeutics Leadership positions in professional societies American Society for Gastrointestinal Endoscopy (Councilor); US Multi-Society Task Forces (AGA, ACG, ASGE) (Chair)

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