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ACTIVE NOT RECRUITING
NCT07149441
NA

Efficacy and Mechanism of FMT in the Treatment of Inflammatory Bowel Disease: an Open-label Randomized Controlled Study

Sponsor: Shanghai 10th People's Hospital

View on ClinicalTrials.gov

Summary

This study enrolled 94 patients with UC or CD. Two groups received either 8-week intestinal bacterial transplant capsule therapy or biological therapy, respectively. The control group received biological therapy alone, while the experimental group received biological therapy combined with FMT. Both groups were followed up for 52 weeks after discharge. The efficacy of FMT capsule therapy on the subjects' UC or CD symptom-related scores and its effect on remodeling the intestinal flora were observed, and its safety was verified.

Official title: Efficacy and Mechanism of Fecal Microbiota Transplantation in the Treatment of Inflammatory Bowel Disease: an Open-label Randomized Controlled Study

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

94

Start Date

2025-08-01

Completion Date

2028-09-01

Last Updated

2025-09-02

Healthy Volunteers

No

Interventions

PROCEDURE

Fecal microbiota transplantation

Fecal microbiota transplantation (FMT) achieves the purpose of treating intestinal and extra-intestinal diseases by transplanting the functional microbes in the feces of healthy people into the patient's intestine through the upper or lower alimentary tract routes to rebuild the patient's intestinal microbiota.

DRUG

infliximab

Intravenous infusion of infliximab once every 8 weeks.

Locations (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China