Testing IFX + mCDED for crohn disease (CD)
Official title: 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
Interventions
IFX + mCDED
modified Crohn's Disease Exclusion Diet (mCDED) ; Diet intervention
Canadian Sites (1)
The University of British Columbia
Vancouver, British Columbia, Canada
Eligibility Criteria
See who this study is looking for24 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
- +Willing to enroll in the CIDsCaNN Network study
Exclusion
- −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)
- −CDED, EEN, or steroids commenced more than 2 weeks prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
- −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
- −Severe perianal disease (fistulizing or ulcerating), fibrostenotic (B2) or penetrating (B3) disease
- −Currently on prednisone/prednisolone for \> 2 weeks
- −Participating in another study
- −Inability to consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- −Pregnant or breastfeeding
- −Bowel surgery prior the randomization
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: IFX + mCDED.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment at all, and is followed for comparison.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 9 years to 17 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 140 people.
The study is currently expected to finish around October 2029.
The main measurement is taken over: 12 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
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 — measured over 12 weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07314606 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About IFX + mCDEDOther
modified Crohn's Disease Exclusion Diet (mCDED) ; Diet intervention
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 9 years to 17 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 9 years to 17 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 12 weeks.
The study as a whole is currently expected to finish around 2029-10-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 140 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Vancouver, British Columbia, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.