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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Crohn's Disease
• Intervention / Treatment: Drug: Infliximab; Drug: Palmitoleic Acid + Infliximab

Detailed Description

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
• Enrollment (Estimated): 400
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Infliximab alone	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.
Experimental: Palmitoleic Acid + Infliximab	Drug: Palmitoleic Acid + Infliximab; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete mucosal healing	Complete mucosal healing is defined as the absence of ulceration, as determined by ileocolonoscopic examination.	From enrollment to the end of treatment at 26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopic remission	Endoscopic remission is defined as a simple endoscopic score for Crohn's Disease (SES-CD) score of <=4. The SES-CD evaluates 4 endoscopic variables-ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis-in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.	From enrollment to the end of treatment at 26 weeks
Endoscopic response	Endoscopic response is defined as a reduction in SES-CD from Baseline by >=50%.	From enrollment to the end of treatment at 26 weeks
Clinical remission	Clinical remission is defined as Crohn's Disease Activity Index (CDAI) of <=150 points. CDAI is a scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.	From enrollment to the end of treatment at 26 weeks
Clinical response	Clinical response is defined as CDAI decrease from Baseline of >=100 points.	From enrollment to the end of treatment at 26 weeks

Collaborators and Investigators

• Sponsor: Chinese Medical Association
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; Sixth Affiliated Hospital, Sun Yat-sen University; Shenzhen University General Hospital; Guangxi Hospital Division of The First Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Palmitoleic acid; Inflammatory bowel disease; Infliximab; Mucosal healing
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Crohn Disease; Inflammatory Bowel Diseases; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Infliximab; palmitoleic acid
• Other Study ID Numbers: POA-IFX-CD-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No