Patients with mild-to-moderate
ulcerative colitis (UC) can achieve deep remission with multidonor faecal microbiota transplantation (FMT) and anti-inflammatory diet, according to an open-label trial. Furthermore, remission can be sustained with anti-inflammatory diet over 1 year.
The trial enrolled 113 patients with mild-to-moderate (Simple Clinical Colitis Activity Index [SCCAI] 3–9) endoscopically active UC (Ulcerative Colitis Endoscopic Index of Severity [UCEIS] >1) on stable baseline medications.
Of the patients, 73 were randomized to treatment with FMT plus anti-inflammatory diet (FMT-AID) or to receive standard medical therapy (SMT) only. The FMT treatment consisted of seven weekly colonoscopic infusions of freshly prepared FMT from multiple donors (weeks 0–6), whereas baseline medications were optimized in the SMT arm.
Researchers followed patients who showed clinical response (decline in SCCAI >3) at week 8 in both arms through week 48. The primary outcome measures were clinical response and deep remission (clinical—SCCAI <2; and endoscopic—UCEIS <1) at 8 weeks, as well as deep remission and steroid-free clinical remission at 48 weeks.
Out of the 73 patients who were randomized, 66 (disease duration 48 months) were included in the modified intention-to-treat analysis, including 35 in the FMT-AID arm and 31 in the SMT arm. The mean age of the overall population was 35.7 years, and 60.1 percent were men. Baseline characteristics were comparable in the treatment arms.
At week 8, FMT-AID proved superior to SMT in terms of inducing clinical response (65.7 percent vs 35.5 percent; p=0.01; odds ratio [OR], 3.5, 95 percent confidence interval [CI], 1.3–9.6), remission (60 percent vs 32.3 percent; p=0.02; OR, 3.2, 95 percent CI, 1.1–8.7), and deep remission (36.4 percent vs 8.7 percent; p=0.03; OR, 6.0, 95 percent CI, 1.2–30.2).
Furthermore, anti-inflammatory diet was more effective than SMT in maintaining deep remission until 48 weeks (25 percent vs 0 percent; p=0.007).