Palmitoleic Acid Combined With Infliximab for Promoting Intestinal Mucosal Healing in Crohn's Disease

Sponsor
Chinese Medical Association
Study ID
NCT07417696
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Palmitoleic Acid + Infliximab — DRUG
    Patients will be administered oral palmitoleic acid at a dose of 720 mg once daily for 26 consecutive weeks, starting at Week 0. Concurrent infliximab will be administered intravenously at the standard dose of 5 mg/kg at Weeks 0, 2, and 6, followed by every 8 weeks thereafter.
  • Infliximab — DRUG
    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.

Study Details

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

Key Dates

First listed
Feb 18, 2026
Start date
Apr 1, 2026
Status verified
Feb 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Palmitoleic Acid + Infliximab
  • Active Comparator: Infliximab alone

Primary Outcome Measure

Complete mucosal healing [ Time Frame: From enrollment to the end of treatment at 26 weeks ]

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