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Diet boosts Crohn's drug in kids: new study hopes to cut meds

NCT ID NCT07314606

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

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

9 to 17 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • The University of British Columbia

    RECRUITING

    Vancouver, British Columbia, V5Z 4H4, Canada

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