Palmitoleic Acid Combined With Infliximab for Promoting Intestinal Mucosal Healing in Crohn's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Palmitoleic Acid + Infliximab, Infliximab.
- Who it may be relevant to
- Registry conditions: Crohn's Disease. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Controlled Trial Investigating the Efficacy of Palmitoleic Acid Combined With Infliximab in Promoting Intestinal Mucosal Healing in Patients With Crohn's Disease
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.
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
- 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. - 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.
Primary outcome measures
- Complete mucosal healing [Time frame: From enrollment to the end of treatment at 26 weeks]
Secondary outcome measures (4)
- Endoscopic remission [Time frame: From enrollment to the end of treatment at 26 weeks]
- Endoscopic response [Time frame: From enrollment to the end of treatment at 26 weeks]
- Clinical remission [Time frame: From enrollment to the end of treatment at 26 weeks]
- Clinical response [Time frame: From enrollment to the end of treatment at 26 weeks]
Eligibility criteria
Inclusion criteria
- Adult patients aged 18 to 75 years.
- Established diagnosis of Crohn's disease confirmed by radiologic, histologic, or endoscopic evidence.
- Active Crohn's disease at screening, defined as a Crohn's Disease Activity Index (CDAI) score between 220 and 450 (inclusive).
- 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.
- Willingness and ability to provide written informed consent.
- Agreement to undergo all scheduled study procedures, including up to 3 endoscopic evaluations.
Exclusion criteria
- Use of any biologic therapy (e.g., infliximab, adalimumab, ustekinumab, vedolizumab) within 8 weeks prior to screening.
- 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.
- History of any intestinal resection or other Crohn's disease-related surgery.
- History of or active chronic or recurrent infectious disease.
- History of or current malignancy.
- Pregnancy, lactation, or intention to become pregnant during the study period.
- Known hypersensitivity to infliximab or palmitoleic acid preparations.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07417696 · POA-IFX-CD-2026