Study of Fecal Microbiota Transplantation to Treat Irritable Bowel Syndrome Assessing Safety and Effectiveness in Adults Aged 18 to 75

What this Trial Is About

Researchers are evaluating fecal microbiota transplantation FMT as a potential treatment for Irritable Bowel Syndrome IBS. FMT involves transferring a healthy donors gut microbiota into a patients colon to restore intestinal flora. This study aims to determine the effectiveness and safety of FMT in patients with IBS, a condition that currently lacks well-established treatments. The trial is sponsored by Guangzhou First Peoples Hospital and includes follow-up assessments over six months. Participants will be randomly assigned to one of three groups receiving FMT through colon infusion of 200 mL donor fecal suspension, receiving a sham infusion, or receiving traditional treatments such as probiotics, antibiotics, or antidepressants as per guidelines. The FMT is administered at least twice, and treatment effects are monitored over time. The study design includes single masking and follows Phase 2 and Phase 3 clinical trial protocols. During the trial, participants will complete questionnaires assessing IBS symptom severity, quality of life, and mental health at the start, and then again at one, three, and six months. Researchers will monitor changes using the IBS Symptom Severity Score IBS-SSS, IBS Quality of Life IBS-QOL questionnaire, and Hamilton Depression and Anxiety Rating Scales. The total participation duration spans at least six months, with evaluations to assess treatment safety and effects throughout this period.

Fecal Microbiota Transplantation for Irritable Bowel Syndrome