NCT01650038 - TURN - Fecal Microbiota Transplantation (FMT) & Ulcerative Colitis (UC)

Study overview:

A double-blind randomized phase II treatment trial (Parallel Assignment) comparing Fecal Microbiota Transplantation (FMT) from healthy donors with autologous Fecal Microbiota Transplantation (FMT) (placebo) in 50 patients with mild to moderately active Ulcerative Colitis (UC) (1)

Primary outcome measures:

Clinical remission, as well as reduction of Mayo endoscopic inflammation score

Results:

Thirty-seven patients completed the primary endpoint assessment. In the intention-to-treat analysis, 30.4% of patients receiving fecal transplants (FMT) from healthy donors and 20.0% of controls achieved the primary endpoint (P = .51). In the per-protocol analysis, 41.2% of FMT recipients and 25.0% of controls achieved the primary endpoint (P = .29). Serious adverse events occurred in 4 patients, with 2 in the FMT group, but were not related to FMT. At 12 weeks, the microbiota of FMT responders resembled that of healthy donors, with remission linked to Clostridium clusters IV and XIVa (1)

Conclusion:

In this phase II trial, researchers found no statistically significant difference in clinical and endoscopic remission between patients with ulcerative colitis (UC) who received fecal transplants from healthy donors and those who received their own fecal microbiota. This lack of difference might be attributed to the limited number of participants. However, the microbiota of patients who responded to the treatment exhibited distinct characteristics compared to those who did not respond, suggesting that further investigation is needed (1)

References:

(1) Rossen et al. 2015 Gastroenterology 149(1): 110-118