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NCT07314606

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

Sponsor: University of British Columbia

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

9 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2025-12-15

Completion Date

2029-10-01

Last Updated

2026-01-08

Healthy Volunteers

Conditions

Crohn Disease (CD)IBD (Inflammatory Bowel Disease)IBD - Inflammatory Bowel Disease

Interventions

OTHER

IFX + mCDED

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

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

Locations (1)

The University of British Columbia

Vancouver, British Columbia, Canada