NCT07415473

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Chinese Medical Association · Network
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, randomized, controlled clinical study designed to evaluate the efficacy of Akkermansia muciniphila combined with infliximab in patients with Crohn's disease. Eligible patients will be randomly assigned to receive either intravenous infliximab at standard clinical doses combined with Akkermansia muciniphila supplementation administered once daily or intravenous infliximab alone. The primary endpoint is complete mucosal healing at Week 26, and the secondary endpoint include endoscopic remission, endoscopic response, clinical remission and clinical response at Week 26.

Conditions

• Crohn's Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-03-31
• Completion: 2029-03-31
• First posted: 2026-02-17
• Last updated: 2026-02-17