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

NCT07415473 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-02-17

No results posted yet for this study

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.

Conditions

  • Crohn's Diseases

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.

Sponsors & Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Sixth Affiliated Hospital, Sun Yat-sen University

    collaborator OTHER

  • Shenzhen University General Hospital

    collaborator OTHER

  • Guangxi Hospital Division of The First Affiliated Hospital, Sun Yat-sen University

    collaborator UNKNOWN

  • Chinese Medical Association

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2029-03-31
Completion
2029-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07415473 on ClinicalTrials.gov