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

Phase 4Not Yet RecruitingNCT07417696

Chinese Medical Association400 enrolled

Overview

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.

This is a prospective, randomized, controlled, open-label clinical study designed to evaluate the efficacy of palmitoleic acid combined with infliximab in patients with Crohn's disease. Eligible patients will be randomly assigned to receive either intravenous infliximab at standard clinical doses plus daily oral palmitic acid supplementation, or intravenous infliximab alone. The primary endpoint is complete mucosal healing at Week 26. Secondary endpoints include endoscopic remission, endoscopic response, clinical remission and clinical response at Week 26.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Crohn's Disease

Interventions

Palmitoleic Acid + InfliximabDRUG

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.

InfliximabDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult patients aged 18 to 75 years. 2. Established diagnosis of Crohn's disease confirmed by radiologic, histologic, or endoscopic evidence. 3. Active Crohn's disease at screening, defined as a Crohn's Disease Activity Index (CDAI) score between 220 and 450 (inclusive). 4. Adequate cardiac, renal, and hepatic function, as assessed by the investigator based on screening laboratory tests, physical examination, and medical history, without findings that would pose an undue risk for study participation. 5. Willingness and ability to provide written informed consent. 6. Agreement to undergo all scheduled study procedures, including up to 3 endoscopic evaluations. Exclusion Criteria: 1. Use of any biologic therapy (e.g., infliximab, adalimumab, ustekinumab, vedolizumab) within 8 weeks prior to screening. 2. Use of supplements containing fish oil or other lipid supplements (e.g., macadamia oil, krill oil, flaxseed, primrose oil, sea buckthorn oil) within 8 weeks prior to screening. 3. History of any intestinal resection or other Crohn's disease-related surgery. 4. History of or active chronic or recurrent infectious disease. 5. History of or current malignancy. 6. Pregnancy, lactation, or intention to become pregnant during the study period. 7. Known hypersensitivity to infliximab or palmitoleic acid preparations.

Outcomes

Primary Outcomes

Complete mucosal healing

Complete mucosal healing is defined as the absence of ulceration, as determined by ileocolonoscopic examination.