NCT07149441

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Shanghai 10th People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis)
• Fecal Microbiota Transplantation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-01
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2025-09-02
• Last updated: 2025-09-02

Locations

1 site across 1 country: China