Randomized controlled trial compares clinical remission rates in ulcerative colitis with FMT, suggesting its potential benefit.
Background: Ulcerative colitis is a chronic inflammatory bowel disease characterized by cycles of relapse and remission. Conventional therapies primarily target immune-mediated inflammation but often fall short in long-term disease control due to side effects, loss of response, and high costs. Fecal microbiota transplantation (FMT), a non-immunosuppressive approach aimed at restoring gut microbial balance, has shown promise in recurrent Clostridioides difficile infections. Its role in ulcerative colitis management, however, remains under investigation. Objective: To compare the frequency of clinical remission with versus without fecal microbiota transplantation in the treatment of ulcerative colitis. Methods: This randomized controlled trial was conducted at the Department of Gastroenterology, AIMC/Jinnah Hospital, Lahore, over six months from September 2021 to March 2022. A total of 180 patients diagnosed with active ulcerative colitis and meeting the inclusion criteria were enrolled and randomized into two groups. Group A received FMT via enema (50 g donor stool in 50 mL infusion) once weekly for six weeks. Group B received a placebo enema (50 mL sterile water) on the same schedule. Clinical remission was defined as a total Mayo score ≤2, assessed via endoscopy before and after the treatment period. Data were analyzed using SPSS v.25. Results: The mean age was 38.81 ± 14.77 years in the FMT group and 37.74 ± 14.29 years in the control group. In the FMT group, 47 patients (52.2%) were male; in the control group, 68 (75.6%) were male. Baseline Mayo scores were similar (8.09 ± 1.50 vs. 7.94 ± 1.44; p = 0.510). After six weeks, the mean Mayo score was significantly lower in the FMT group (4.63 ± 2.40) than in controls (5.48 ± 2.18) (p = 0.015). Clinical remission was achieved in 32 (35.6%) patients in the FMT group and 17 (18.9%) in the control group (p = 0.012). Conclusion: FMT was associated with a significantly higher clinical remission rate compared to standard treatment and may serve as a reliable adjunctive therapy for managing active ulcerative colitis.
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