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RECRUITING
NCT07387952
NA

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

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

Summary

Chronic constipation is a common gastrointestinal disease with a global prevalence of about 15%, significantly affecting daily life and quality of life. Traditional treatments primarily rely on laxatives, which may lead to adverse effects with prolonged use, while surgical interventions have limited patient acceptance. Recent studies indicate that gut microbiota therapies-including probiotics, prebiotics, synbiotics, postbiotics, and fecal microbiota transplantation (FMT)-can effectively manage chronic constipation. This study aims to investigate the safety and efficacy of FMT combined with a prebiotic nutritional intervention (using a co-localization strategy) in the treatment of functional constipation. Additionally, the investigators will explore changes in fecal microbiota and metabolomic profiles following the treatment.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

5

Start Date

2025-07-30

Completion Date

2026-12-31

Last Updated

2026-02-04

Healthy Volunteers

No

Interventions

PROCEDURE

FMT

In this group, colonoscopy is performed and a colostomy is placed in the ileocecal region. Bacterial infusion is performed for 3 days with 100ml graft per day. Within 30 minutes after receiving the microbiota transplantation, take the high dietary fiber preparation and dissolve it in water according to the instructions. Blood, stool, and colonoscopy-derived mucosal samples are collected before and after FMT and Researchers conduct follow-ups.

Locations (1)

Peking Union Medical College Hospital

Beijing, China