About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- IFX + mCDED