Efficacy and Safety of Fecal Microbiota Transplantation in Reducing Recurrence of Colorectal Adenomas After Endoscopic Resection: a Multicenter, Open-label, Randomized Controlled Study

What this Trial Is About

Colorectal adenomas are precancerous growths that can lead to colorectal cancer if not properly treated. This clinical trial is investigating the safety and effectiveness of fecal microbiota transplantation (FMT) in reducing the recurrence of these adenomas after they have been removed by endoscopic resection. The study also aims to understand how the intestinal and mucosal microbiota change before and after both the endoscopic treatment and FMT. Participants will be randomly assigned to receive either FMT or no treatment. Those in the FMT group will have 150ml of fecal suspension infused into their terminal ileum during a colonoscopy on day 0. This will be followed by taking oral FMT capsules for two days (40 capsules per day, split into two doses). Maintenance treatment with oral FMT capsules will continue at 3, 6, and 9 months. Follow-up colonoscopy will occur between 6 to 12 months depending on the participant's risk level. Throughout the study, participants will undergo colonoscopies to monitor adenoma recurrence and stool samples will be collected to analyze changes in gut microbiota. Safety will be assessed by tracking any adverse events related to FMT. The main outcome measured is the rate of adenoma recurrence within 6 to 12 months after treatment. The total study duration includes initial treatment, maintenance, and follow-up assessments up to 12 months.

Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Reducing Recurrence of Colorectal Adenoma (CRA)