NCT07417696

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
35mo left

Started Apr 2026

Typical duration for phase_4

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Mar 2029

First Submitted

Initial submission to the registry

February 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

February 11, 2026

Last Update Submit

February 11, 2026

Conditions

Crohn's Disease

Keywords

InfliximabPalmitoleic acidMucosal healingInflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Endoscopic remission

    From enrollment to the end of treatment at 26 weeks

  • Endoscopic response

    From enrollment to the end of treatment at 26 weeks

  • Clinical remission

    From enrollment to the end of treatment at 26 weeks

  • Clinical response

    From enrollment to the end of treatment at 26 weeks

Study Arms (2)

Palmitoleic Acid + Infliximab

EXPERIMENTAL
Drug: Palmitoleic Acid + Infliximab

Infliximab alone

ACTIVE COMPARATOR
Drug: Infliximab

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.

Palmitoleic Acid + Infliximab
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.

Infliximab alone

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Crohn DiseaseInflammatory Bowel Diseases

Interventions

palmitoleic acidInfliximab

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician, Professor

Study Record Dates

First Submitted

February 11, 2026

First Posted

February 18, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2029

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share