Meta-Analysis Finds High Rates of Clinical, Endoscopic Remission Among Patients With UC Treated With FMT

Findings from a recent meta-analysis of randomized controlled trials using fecal microbiota transplantation (FMT) to treat ulcerative colitis (UC) are highlighting its potential to induce clinical and endoscopic remission.

“Several countries have conducted research to examine the effectiveness and safety of FMT as a treatment for UC. However, there is inconsistency in the methods utilized across these studies, leading to varying results,” wrote investigators.¹ “As such, there is a need to further consider both the efficacy and safety of FMT for the treatment of UC.”

Although there is no known cure for UC, treatment options often seek to reduce inflammation and induce remission through pharmacological approaches such as aminosalicylates, corticosteroids, immunomodulators, biologics, and JAK inhibitors.² Research shows fecal transplants may help reduce intestinal irritation caused by UC by restoring healthy bacteria in the lower intestine, but evidence of its safety and efficacy as a treatment for UC is limited.³

To assess the efficacy and safety of FMT as a treatment for UC, a team of investigators representing multiple institutions in Asia conducted a comprehensive systematic review and meta-analysis of randomized controlled trials comparing remission and adverse reaction rates between FMT and control groups. Investigators searched databases for original research, published in English, examining FMT as an intervention in patients with UC. Reviews, conference papers, studies involving animals, in vitro trials, case–control studies, case series reports, and cohort studies were excluded from analysis.¹

Data from the studies were independently identified and compiled by 2 investigators who then cross-checked results to ensure consistency. The initial search yielded 4423 articles. Investigators identified 13 randomized controlled trials on the efficacy of FMT in patients with UC based on the study’s criteria for inclusion. The selected studies included 580 participants, primarily mild to moderate UC patients with a Mayo score of 4–10 and an endoscopic Mayo subscore of ≥ 1. Among all participants, 293 patients were treated with FMT through colonoscopy, enema, oral capsule, or nasoduodenal tube transplantation and 287 control patients received placebo, autologous FMT, 5-ASA, or standard drug therapy.¹

Differences in rates of remission and adverse reactions between the FMT group and the control group were determined using the risk ratio (RR) and 95% confidence interval (CI) to combine findings. Investigators conducted subgroup analyses based on factors including delivery method, donor type, evaluation time, total dose of FMT, control mode, and literature publication time. Investigators used the Cochrane risk of bias tool to evaluate bias in all of the studies. Heterogeneity was assessed using the Chi2 test, and the I2 index was used as an index of heterogeneity.¹

Upon analysis, clinical remission was achieved in 50.17% of patients in the FMT group compared to 29.02% of patients in the control group, suggesting the FMT group had significantly better clinical remission than the control group (RR, 1.73; 95% CI, 1.41-2.12; P < .00001). Investigators also noted significant differences in the achievement of endoscopic remission between the groups, pointing out 26.82% of FMT patients achieved remission compared to 15.60% of the control group (RR, 1.74; 95% CI, 1.24-2.44; P = .001).¹

Further analysis revealed 39.93% of patients in the FMT group experienced adverse reactions compared to 40.94% of patients in the control group. Investigators pointed out the results were not statistically significant (RR, 1.00; 95% CI, 0.86-1.15; P = .96), suggesting no significant difference in the incidence of adverse reactions between the two groups.¹

“FMT is a promising treatment for UC, with demonstrated clinical and endoscopic remission rates. However, the concerns around its safety during treatment require additional attention and improved measures to ensure its safety. By focusing on improving safety measures and success rates, we can gain a better understanding of how effective and safe this approach truly is,” concluded investigators.¹

References:

1. Feng J, Chen Y, Liu Y, et al. Efficacy and safety of fecal microbiota transplantation in the treatment of ulcerative colitis: a systematic review and meta-analysis. Sci Rep 13, 14494 (2023). https://doi.org/10.1038/s41598-023-41182-6
2. Cleveland Clinic. Ulcerative Colitis. Diseases & Conditions. Accessed September 6, 2023. https://my.clevelandclinic.org/health/diseases/10351-ulcerative-colitis#management-and-treatment
3. Johns Hopkins Medicine. Fecal Transplant. Treatments, Tests & Therapies. Accessed September 6, 2023. https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/fecal-transplant