Diet boosts Crohn's drug in kids: new study hopes to cut meds
NCT ID NCT07314606
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding a special diet (Crohn's Disease Exclusion Diet) to the standard drug infliximab helps children with Crohn's disease feel better and stay in remission longer. About 140 children starting infliximab will be randomly assigned to receive the diet plus drug or drug alone. The goal is to improve treatment response and reduce long-term medication needs.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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9 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The University of British Columbia
RECRUITINGVancouver, British Columbia, V5Z 4H4, Canada
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