Infliximab plus the Crohn's Disease Exclusion Diet for children with Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, randomized controlled study comparing infliximab (IFX) alone versus IFX combined with a modified Crohn's Disease Exclusion Diet (mCDED) in pediatric patients with luminal Crohn's disease. After up to 4 months of baseline data collection, 140 children will be randomized 1:1 and followed for 12 months with standardized IFX infusions and dietitian support for the mCDED arm. Primary outcomes focus on clinical response by week 12 and clinical/biochemical remission at week 52, with serial diet records, inflammatory markers, and other samples collected. The control arm receives the same IFX schedule and dietitian review of usual intake but is not asked to follow the exclusion diet.

Why it matters

Who can join: the full rules

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

Where it's running

• The University of British Columbia
  Vancouver, British Columbia, Canada Recruiting

Study contacts

• Principal investigator: Kevan Jacobson, MBBCh, FRCP, FRCPC, AGAF, CAGF — The University of British Columbia
• Study coordinator: Kevan Jacobson, MBBCh, FRCP, FRCPC, AGAF, CAGF
• Email: kjacobson@cw.bc.ca
• Phone: 604-875-2332

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.