RecruitingNot ApplicableNCT07314606

Combining Nutritional Therapy and Anti-TNFα Treatment in Pediatric Patients With Crohn's Disease

Open-Label Multicentre Randomized Dietary Intervention Study in Pediatric Crohn's Disease Patients Initiating Anti-TNF Therapy

Sponsor

University of British Columbia

Enrollment

140 participants

Start Date

Apr 22, 2026

Study Type

INTERVENTIONAL

Conditions

IBD (Inflammatory Bowel Disease)Crohn Disease (CD)

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.

Eligibility

Min Age: 9 YearsMax Age: 17 Years

Inclusion Criteria12

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 Criteria12

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