Infliximab plus the Crohn's Disease Exclusion Diet for children with Crohn's disease
Open-Label Multicentre Randomized Dietary Intervention Study in Pediatric Crohn's Disease Patients Initiating Anti-TNF Therapy
This will test whether starting a Crohn's Disease Exclusion Diet at the same time as infliximab helps children with moderate-to-severe Crohn's disease get better and stay in remission.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 9 Years to 17 Years |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Drugs / interventions | Methotrexate, prednisone, infliximab |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT07314606 on ClinicalTrials.gov |
What this trial studies
This is an open-label, randomized controlled study comparing infliximab (IFX) alone versus IFX combined with a modified Crohn's Disease Exclusion Diet (mCDED) in pediatric patients with luminal Crohn's disease. After up to 4 months of baseline data collection, 140 children will be randomized 1:1 and followed for 12 months with standardized IFX infusions and dietitian support for the mCDED arm. Primary outcomes focus on clinical response by week 12 and clinical/biochemical remission at week 52, with serial diet records, inflammatory markers, and other samples collected. The control arm receives the same IFX schedule and dietitian review of usual intake but is not asked to follow the exclusion diet.
Who should consider this trial
Good fit: Children with moderate-to-severe active luminal Crohn's disease (wPCDAI ≥ 40 or strong clinical suspicion) within 12 months of diagnosis, naïve to biologic therapy, with objective inflammation (FCP > 250 µg/g and/or CRP > 5 mg/L or ESR > 20 mm/hr) and BMI between the 5th and 95th percentiles who are planned to start infliximab and can follow dietary recommendations are ideal candidates.
Not a fit: Patients already on biologic therapy, those with significant malnutrition or disease phenotypes that are primarily stricturing or penetrating, or those unwilling/unable to follow the diet are unlikely to benefit from this dietary intervention.
Why it matters
Potential benefit: If successful, combining mCDED with infliximab could increase remission rates, reduce overall drug exposure, and support better growth and long-term health in children with Crohn's disease.
How similar studies have performed: Prior pediatric studies have shown the Crohn's Disease Exclusion Diet can induce remission and improve outcomes, but starting mCDED concurrently with infliximab is a more novel approach with limited direct evidence to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Vancouver, British Columbia
- The University of British Columbia — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Kevan Jacobson, MBBCh, FRCP, FRCPC, AGAF, CAGF — The University of British Columbia
- Study coordinator: Kevan Jacobson, MBBCh, FRCP, FRCPC, AGAF, CAGF
- Email: kjacobson@cw.bc.ca
- Phone: 604-875-2332
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.