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.
Eligibility
Sex
ALL
Min age
9 Years
Max age
17 Years
Healthy volunteers
No
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
Primary outcome measure(s)
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. — 12 weeks Clinical response: defined as mild or inactive clinical disease (at least a 17.5-points decrease in weighted paediatric Crohn's disease activity index (wPCDAI) from baseline, with a score \< 40), physician global assessment (PGA) of inactive or mild disease activity, off steroids, continuation on the same anti-TNFα dose, and remaining surgery-free.
Biochemical response: Defined as at least a 50% decrease in fecal calprotectin (FCP) levels compared to baseline.
wPCDAI ranges from 0 to 125, with higher scores indicating greater disease activity.
PGA ranges from 0 to 10, with higher scores indicating greater disease activity.
Trial sites (1)
Facility
City
Region
Status
The University of British Columbia
Vancouver
British Columbia
Recruiting
More University of British Columbia trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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