Combining Nutritional Therapy and Anti-TNFα Treatment in Pediatric Patients With Crohn's Disease (NCT07314606) | Clinical Trial Compass
RecruitingNot Applicable
Combining Nutritional Therapy and Anti-TNFα Treatment in Pediatric Patients With Crohn's Disease
Canada140 participantsStarted 2026-04-22
Plain-language summary
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.
Who can participate
Age range
9 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 produc…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.