Crohn's Disease
Conditions
Keywords
Infliximab, Palmitoleic acid, Mucosal healing, Inflammatory bowel disease
Brief summary
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.
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.
Interventions
DRUGPalmitoleic 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.
DRUGInfliximab
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.
Sponsors
Chinese Medical Association
First Affiliated Hospital, Sun Yat-Sen University
Guangxi Hospital Division of The First Affiliated Hospital, Sun Yat-sen University
Sixth Affiliated Hospital, Sun Yat-sen University
Shenzhen University General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete mucosal healing | From enrollment to the end of treatment at 26 weeks | Complete mucosal healing is defined as the absence of ulceration, as determined by ileocolonoscopic examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic remission | From enrollment to the end of treatment at 26 weeks | 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. |
| Endoscopic response | From enrollment to the end of treatment at 26 weeks | Endoscopic response is defined as a reduction in SES-CD from Baseline by \>=50%. |
| Clinical remission | From enrollment to the end of treatment at 26 weeks | 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. |
| Clinical response | From enrollment to the end of treatment at 26 weeks | Clinical response is defined as CDAI decrease from Baseline of \>=100 points. |
Outcome results
None listed