Special diet started together with infliximab for children with Crohn's disease

Trial details

Who runs it

University of British Columbia

Trial code

NCT07314606

Record updated

1 May 2026

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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: CDED, EEN, or steroids commenced more than 2 weeks prior to randomization; Bowel surgery prior the randomization; Currently on prednisone/prednisolone for > 2 weeks; Other known GI disorders (except IBS), food intolerances or chronic diseases; Severe perianal disease (fistulizing or ulcerating), fibrostenotic (B2) or penetrating (B3) disease; 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); Pregnant or breastfeeding; Participating in another study; Inability to consent.

ClinicalTrials.gov NCT07314606