Actively Recruiting
Open-Label Multicentre Randomized Dietary Intervention Study in Pediatric Crohn's Disease Patients Initiating Anti-TNF Therapy
Led by University of British Columbia · Updated on 2026-05-01
140
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the impact of combining a specialized nutritional therapy, the modified Crohn's Disease Exclusion Diet (mCDED), with the biologic drug infliximab in children aged 9 to 17 years diagnosed with moderate to severe active luminal Crohn's disease. The goal is to improve treatment responses, reduce medication exposure, and support better long-term health outcomes for pediatric patients who often face growth issues and frequent hospitalizations due to this inflammatory bowel disease. This open-label, randomized controlled study aims to compare the effects of infliximab alone versus infliximab combined with mCDED over a year.
CONDITIONS
Brief Title
Combining Nutritional Therapy and Anti-TNFα Treatment in Pediatric Patients With Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 9 to 17 years
- Diagnosed with moderate to severe active luminal Crohn's disease (B1) affecting ileal and/or colonic regions
- Planned to start infliximab therapy by treating physician
- Within 12 months of Crohn's disease diagnosis at treatment start
- No previous biologic therapy use
- For established disease with flare-ups, no response to dietary intervention or steroids within 4 weeks
- For newly diagnosed, no response to dietary intervention or steroids within 2 weeks
- Evidence of active inflammation shown by elevated fecal calprotectin, CRP, or ESR
- Body mass index between 5th and 95th percentiles for age and sex
- On steroids or exclusive enteral nutrition for less than 2 weeks (new patients) or less than 4 weeks (established disease)
- Able and willing to follow dietary recommendations
- On stable dose of azathioprine or methotrexate at randomization
- Willing to enroll in the Canadian Children Inflammatory Bowel Disease Network study
You will not qualify if you...
- Started Crohn's Disease Exclusion Diet, exclusive enteral nutrition, or steroids more than 2 weeks before randomization
- Antibiotic use within last 2 months (except short courses between 1-2 months prior) or laxative use within past month (except for bowel prep)
- Use of prebiotics, probiotics, or synbiotics supplements in the last month (food containing these allowed)
- Strict vegetarian or vegan diet
- High risk of malnutrition as assessed by Pediatric Yorkhill Malnutrition Score
- Other gastrointestinal disorders (except IBS), food intolerances, or chronic diseases
- Previous bowel surgery before randomization
- Severe perianal disease, fibrostenotic or penetrating Crohn's disease
- On prednisone or prednisolone for more than 2 weeks
- Pregnant or breastfeeding
- Participating in another clinical study
- Unable to provide consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 months
Participants are screened for eligibility to participate in the trial.
1 to 2 visits for baseline sample and data collection
Duration - 12 months
Participants begin infliximab therapy and either follow the modified Crohn's Disease Exclusion Diet (mCDED) with dietitian support or continue their usual diet with dietitian review. Treatment includes scheduled infliximab infusions and dietary interventions for 12 months.
Visits aligned with infliximab infusion schedule and regular dietitian consultations
Duration - Up to 12 months concurrent with treatment duration
Participants undergo assessments including clinical, biochemical, imaging, and dietary evaluations to monitor disease activity and response to treatment through the 12-month period.
Multiple visits for clinical assessments, imaging (MRI, ultrasound), colonoscopy at baseline and week 52, and sample collections at specified weeks
Trial Site Locations
Total: 1 location
1
The University of British Columbia
Vancouver, British Columbia, Canada, V5Z 4H4
Actively Recruiting
Research Team
K
Kevan Jacobson, MBBCh, FRCP, FRCPC, AGAF, CAGF
F
Fanny Lemarie, MSc, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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