Clinical trial for Crohn Disease (CD)
Official title Combining Nutritional Therapy and Anti-TNFα Treatment in Pediatric Patients With Crohn's Disease
ClinicalTrials.gov ID: NCT07314606
What this study is testing
- What it's testing
- The study wants to see whether starting the Crohn’s Disease Exclusion Diet (CDED) at the same time as infliximab improves treatment outcomes and reduces the need for the drug.
- Who it's for
- It is looking for children who have Crohn’s disease and are already receiving or will start infliximab therapy.
- What's involved
- Participants will follow the CDED diet while receiving infliximab, and will have regular clinic visits and medical tests to monitor their health and response to treatment.
- Time commitment
- The study lasts for the period of infliximab treatment, with scheduled visits and diet monitoring throughout that time.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 9 to 17
You may be able to join if
- Moderate-severe active luminal inflammatory (B1) pCD [wPCDAI \> or = 40] ileal +/- colonic (L1, L2, L3), and in whom treating physician plans to...
- OR Strong suspicion of moderate-severe active luminal inflammatory (B1) pCD ileal +/- colonic (L1, L2, L3), and in whom treating physician plans to...
- 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.
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 9 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Vancouver, British Columbia, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.