Pilot Study of Safety and Effectiveness of Fecal Microbiota Transplantation Combined With Dietary Fiber for Treating Functional Constipation

What this Trial Is About

Functional constipation is a common gastrointestinal condition affecting about 15% of people worldwide, significantly impacting daily life and quality of life. This research aims to evaluate the safety and effectiveness of combining fecal microbiota transplantation FMT with a prebiotic nutritional intervention in treating this condition. The study also seeks to understand changes in gut bacteria and metabolic profiles after treatment. Participants in the study receive FMT through colonoscopy, where beneficial bacteria from a healthy donor are transplanted into the digestive system to restore balance. This is combined with taking a high dietary fiber preparation dissolved in water shortly after the transplantation. Samples of blood, stool, and colon tissue are collected before and after treatment to monitor effects, and follow-up visits are conducted to assess progress. During the trial, researchers will track bowel movement frequency, stool consistency using the Bristol Stool Form Scale, and the severity of straining during defecation at multiple time points up to 24 weeks. They will also monitor any treatment-related side effects and analyze changes in gut microbiota composition through genetic sequencing. The study runs from baseline through follow-ups at weeks 2, 4, 8, 12, 18, and 24, with comprehensive participant evaluations throughout.

The Safety and Efficacy of Fecal Microbiota Transplantation Combined With Nutritional Intervention in the Treatment of Functional Constipation：a Pilot Study