Crohn's DiseasePhase 4NCT07417696
Palmitoleic Acid Combined With Infliximab for Promoting Intestinal Mucosal Healing in Crohn's Disease
A Phase 4 study testing Palmitoleic Acid + Infliximab and Infliximab in people with Crohn's Disease, run by Chinese Medical Association.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Palmitoleic Acid + Infliximab and Infliximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Mar 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
Read the 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.
- Conditions
- Crohn's Disease
- Being tested
- Palmitoleic Acid + Infliximab, Infliximab
- Keywords
- Infliximab, Palmitoleic acid, Mucosal healing, Inflammatory bowel disease
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Palmitoleic Acid + Infliximab | Experimental | Not described Receives: Drug: Palmitoleic Acid + Infliximab |
| Infliximab alone | Active comparator | Not described Receives: Drug: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete mucosal healing
Complete mucosal healing is defined as the absence of ulceration, as determined by ileocolonoscopic examination.
Measured: From enrollment to the end of treatment at 26 weeks
Secondary outcomes (4)
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.
Measured: 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%.
Measured: 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.
Measured: From enrollment to the end of treatment at 26 weeks
Clinical response
Clinical response is defined as CDAI decrease from Baseline of >=100 points.
Measured: From enrollment to the end of treatment at 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Medical Association
- Sponsor type
- Research network
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Sixth Affiliated Hospital, Sun Yat-sen University, Shenzhen University General Hospital
- Responsible party
- Principal investigator, Sheng-hong Zhang, Chinese Medical Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417696
- Sponsor's protocol ID
- POA-IFX-CD-2026
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07417696
- Acronym / sponsor ID
- POA-IFX-CD-2026
- Conditions
- Crohn's Disease
- Keywords
- Infliximab, Palmitoleic acid, Mucosal healing, Inflammatory bowel disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Chinese Medical AssociationResearch network
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Sixth Affiliated Hospital, Sun Yat-sen University, Shenzhen University General Hospital
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palmitoleic Acid + Infliximab | Experimental | Drug: Palmitoleic Acid + Infliximab |
| Infliximab alone | Active comparator | Drug: Infliximab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palmitoleic Acid + InfliximabPatients 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 | Palmitoleic Acid + Infliximab |
| InfliximabPatients 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. | Drug | Infliximab alone |
Primary outcome
Complete mucosal healing
Time frame: 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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Palmitoleic Acid + Infliximab and Infliximab in people with Crohn's Disease, run by Chinese Medical Association.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete mucosal healing (time frame: From enrollment to the end of treatment at 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.