Recruiting

CDED & Infliximab

Sponsor:

University of British Columbia

Code:

NCT07314606

Conditions

Crohn Disease (CD)

IBD (Inflammatory Bowel Disease)

IBD - Inflammatory Bowel Disease

Eligibility Criteria

Sex: All

Age: 9 - 17

Healthy Volunteers: Not accepted

Interventions

IFX + mCDED

Study Details

Brief summary:

Children with Crohn's disease (CD), a type of Inflammatory Bowel Disease (IBD), often face serious health challenges, including poor growth, frequent hospital stays, and long-term medication use. Although biologic drugs like infliximab, an anti-TNFα (Tumor necrosis factor α) medication, have improved treatment, they don't work for everyone: many children still experience symptoms or disease flare-ups. Nutritional therapies, especially the Crohn's Disease Exclusion Diet (CDED), may help improve treatment outcomes. This study will assess whether starting CDED at the same time as infliximab leads to better responses to treatment. The goal of this study is to improve how well children respond to therapy, reduce drug exposure, and support better long-term health.

Conditions

Crohn Disease (CD)

IBD (Inflammatory Bowel Disease)

IBD - Inflammatory Bowel Disease

Study ID

NCT07314606

Start date

Apr 22, 2026

Status verified date

Apr, 2026

Completion date

Oct 1, 2029

Anticipated

Primary completion date

Oct 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Moderate-severe active luminal inflammatory (B1) pCD \[wPCDAI > or = 40\] ileal +/- colonic (L1, L2, L3), and in whom treating physician plans to start IFX
  • OR Strong suspicion of moderate-severe active luminal inflammatory (B1) pCD ileal +/- colonic (L1, L2, L3), and in whom treating physician plans to start IFX
  • Within 12-months of diagnosis (when starting IFX treatment)
  • Naïve to a biologic therapy
  • For patients with established disease who flare up: no response to dietary intervention or steroids within 4 weeks of commencement of these therapies.
  • For newly diagnosed patients: no response to dietary intervention or steroids within 2 weeks of commencement of these therapies.
  • Evidence of active inflammation: FCP level > 250 µg/g and/ or CRP > 5 mg/L or ESR > 20 mm/hr
  • BMI between the 5th and 95th percentiles, adjusted for age and sex
  • On steroids or EEN for less than 2 (or 4, for established disease) weeks
  • Able and willing to follow dietary recommendations
  • On stable dose of AZA or Methotrexate (MTX) at randomization
  • Willing to enroll in the CIDsCaNN Network study

Exclusion Criteria:

  • CDED, EEN, or steroids commenced more than 2 weeks prior to randomization
  • Antibiotic use in the last 2 months (except short course < 1 week between 1-2 months) or laxative use within the past month (except for bowel prep for endoscopy pre commencement of anti-TNFα)
  • Pre-, pro-, synbiotic supplements in the last month (food containing these products, e.g. yogurt, allowed)
  • Strict vegetarians and vegans
  • High risk of malnutrition as assessed by the Paediatric Yorkhill Malnutrition Score (PYMS)
  • Other known GI disorders (except IBS), food intolerances or chronic diseases
  • Bowel surgery prior the randomization
  • Severe perianal disease (fistulizing or ulcerating), fibrostenotic (B2) or penetrating (B3) disease
  • Currently on prednisone/prednisolone for > 2 weeks
  • Pregnant or breastfeeding
  • Participating in another study
  • Inability to consent

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IFX + mCDED

Participants will follow the modified Crohn's disease exclusion diet (mCDED) for 6 months, when initiating their infliximab therapy as part of their routine care

no intervention: IFX

Participants will initiate their infliximab therapy as part of their routine care

Interventions

IFX + mCDED

modified Crohn's Disease Exclusion Diet (mCDED) ; Diet intervention

Primary outcome measure

  • Clinical and biochemical response at the first infliximab (IFX) maintenance dose (week 12) in participants receiving mCDED alongside IFX compared with participants receiving IFX alone. [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Kevan Jacobson, MBBCh, FRCP, FRCPC, AGAF, CAGF

604-875-2332kjacobson@cw.bc.ca

Fanny Lemarie, MSc, PhD

604-441-4992fanny.lemarie@ubc.ca

Locations

The University of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V5Z 4H4

Contacts

Kevan Jacobson, MBBCh, FRCP, FRCPC, AGAF, CAGF

604-875-2332kjacobson@cw.bc.ca

Fanny Lemarie, MSc, PhD

604-441-4992fanny.lemarie@ubc.ca

More Information

Sponsor

University of British Columbia

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • CDED
  • Exclusion Diet
  • Infliximab
  • Nutritional therapy
  • Pediatric
  • Diet Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-05-01.