Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis

Area of Science:

• Gastroenterology
• Microbiome Research
• Immunology

Background:

• Ulcerative colitis (UC) is a chronic inflammatory bowel disease.
• Fecal microbiota transplantation (FMT) has shown promise in case series for UC treatment.
• Efficacy and safety of FMT in UC require rigorous evaluation.

Purpose of the Study:

• To assess the efficacy and safety of FMT for patients with mild to moderately active UC.
• To compare FMT with healthy donor microbiota versus autologous fecal microbiota.
• To investigate changes in gut microbiota composition post-FMT.

Main Methods:

• A double-blind, randomized trial involving 50 UC patients.
• FMT administered via nasoduodenal tube at baseline and 3 weeks.
• Primary endpoint: clinical and endoscopic remission at 12 weeks.
• Secondary endpoints: safety and microbiota analysis using phylogenetic microarray.

Main Results:

• No statistically significant difference in remission rates between FMT and control groups (30.4% vs 20.0% ITT; 41.2% vs 25.0% PP).
• No FMT-related serious adverse events were reported.
• Responders in the FMT group showed microbiota similar to donors, with specific Clostridium clusters linked to remission.

Conclusions:

• FMT did not demonstrate statistically significant efficacy over autologous microbiota for UC remission in this phase 2 trial.
• Limited patient numbers may have impacted statistical power.
• Distinct microbial features in responders suggest potential for targeted microbiome-based therapies in UC.