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Compares treatment options for Crohn's Disease
Official title Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients.
ClinicalTrials.gov ID: NCT04777656
What this study is testing
- What it's testing
- This research is a multicenter French randomized and single blinded phase III clinical trial evaluating two treatment strategies among Crohn's disease (CD) patients. The main objective is to assess if the addition of Crohn's Disease Exclusion Diet (CDED) to ongoing standard medication is superior to reduce the rate of relapses over 12 months compared to standard medication alone in children/adolescents with unstable CD responding with remission after a 2-months course of CDED
- Phase 3: a large, late-stage study
- Time commitment: about 12 months
- 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 6 to 17
You may be able to join if
- Child/Adolescent aged 6-17 years with a confirmed diagnosis of CD (for at least 3 months) with an active disease (defined as: wPCDAI \>12.5 or CRP \>...
- For girls of childbearing age: a negative pregnancy test, and use of an effective method of contraception (abstinence, oral contraceptives...
- Patient willing to comply with daily intake of an exclusion diet
- Informed and signed consent of parents
- Patient affiliated to social security (or health insurance)
You likely can't join if
- Active perianal fistulizing disease
- Internal fistula or evidence of un-drained and un-controlled abscess/phlegmon
- Patient who require CD-related surgical therapy
- Patient with known allergy to cow milk's proteins
- Patient incapable to follow CDED for a prolonged period
- Pregnancy, breastfeeding
See the full eligibility criteria
- Child/Adolescent aged 6-17 years with a confirmed diagnosis of CD (for at least 3 months) with an active disease (defined as: wPCDAI \>12.5 or CRP \> 2 times upper limit or calprotectin levels \>250µg/g if available)...
- For girls of childbearing age: a negative pregnancy test, and use of an effective method of contraception (abstinence, oral contraceptives, intra-uterine device, diaphragm with spermicide and condom)
- Patient willing to comply with daily intake of an exclusion diet
- Informed and signed consent of parents
- Patient affiliated to social security (or health insurance)
- Active perianal fistulizing disease
- Internal fistula or evidence of un-drained and un-controlled abscess/phlegmon
- Patient who require CD-related surgical therapy
- Patient with known allergy to cow milk's proteins
- Patient incapable to follow CDED for a prolonged period
- Pregnancy, breastfeeding
- Patient already included in an treatment study
The study team makes the final eligibility decision.
Where it's taking place
- Bron, France
- Caen, France
- Marseille, France
- Paris, France
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 - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bron, France; Caen, France; Marseille, France; Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.