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NOT YET RECRUITING
NCT07415473
PHASE4

Akkermansia Muciniphila Combined With Infliximab for Promoting Intestinal Mucosal Healing in Crohn's Disease

Sponsor: Chinese Medical Association

View on ClinicalTrials.gov

Summary

This study aims to evaluate whether the combination of Akkermansia muciniphila with infliximab can improve intestinal mucosal healing in patients with Crohn's disease compared with infliximab alone.

Official title: A Randomized, Controlled Trial Investigating the Efficacy of Akkermansia Muciniphila Combined With Infliximab in Promoting Intestinal Mucosal Healing in Patients With Crohn's Disease

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2026-04-01

Completion Date

2029-03-31

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

DRUG

Infliximab

Patients will receive infliximab alone administered intravenously at the standard dose of 5 mg/kg at Weeks 0, 2, and 6, followed by every 8 weeks thereafter.

DRUG

Akkermansia muciniphila + Infliximab

Patients will receive oral Akkermansia muciniphila once daily starting at Week 0. Concurrently, they will receive intravenous infliximab at the standard dose of 5 mg/kg at Weeks 0, 2, and 6, followed by every 8 weeks thereafter.