Crohn'sRecruiting
Combining Nutritional Therapy and Anti-TNFα Treatment in Pediatric Patients With Crohn's Disease
Not applicable · Testing IFX + mCDED · 1 site · University of British Columbia
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing IFX + mCDED as a possible treatment. Condition(s) listed: Crohn Disease (CD), IBD (Inflammatory Bowel Disease) and IBD - Inflammatory Bowel Disease.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 9 to 17
- Any sex
Some of the main requirements, copied from the record:
- 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)
Plus 9 more requirement(s). There are also 12 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 140 participants are expected to take part.
- Start date: 2026-04-22.
- Main results expected around 2029-10-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Canada.
Main thing being measured
- Clinical and biochemical response at the first infliximab (IFX) maintenance dose (week 12) in participants receiving mCDED alongside IFX compared with participants receiving IFX alone. (12 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease (CD); IBD (Inflammatory Bowel Disease); IBD - Inflammatory Bowel Disease |
| Lead sponsor | University of British Columbia |
| Enrollment | 140 (estimated) |
| Start date | 2026-04-22 |
| Primary completion (est.) | 2029-10-01 |
| First posted | 2026-01-02 |
| Last updated | 2026-05-01 |
| Official title | Open-Label Multicentre Randomized Dietary Intervention Study in Pediatric Crohn's Disease Patients Initiating Anti-TNF Therapy |
| ClinicalTrials.gov ID | NCT07314606 |
Interventions
- IFX + mCDED (Other)
modified Crohn's Disease Exclusion Diet (mCDED) ; Diet intervention
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| The University of British Columbia | Vancouver, British Columbia | Canada | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.