NCT07314606Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 1 May 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Study type: Interventional
Enrollment: 140 (estimated)
First submitted: 29 Sept 2025
Start date: Apr 2026
Primary completion date: Oct 2029
Lead sponsor: University of British Columbia
Diseases: Crohn's disease
NCT number: NCT07314606

What you commit to

Study type: Interventional
Planned participants: 140
From Apr 2026 to the primary completion date, Oct 2029
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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 illness

Other known GI disorders (except IBS), food intolerances or chronic diseases
Severe perianal disease (fistulizing or ulcerating), fibrostenotic (B2) or penetrating (B3) disease

Other

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

Who the study is looking for

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

Age in the registry: 9 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
The University of British Columbia Coordinator of this site? Confirm its status	Vancouver	Canada	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.