Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients.
Phase 3 · Testing Phase1 : CDED/Modulen™IBD® + Maintenance therapy and Phase2 and 3 : · 4 sites · Assistance Publique - Hôpitaux de Paris
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Phase1 : CDED/Modulen™IBD® + Maintenance therapy (a dietary supplement) and Phase2 and 3 : (a dietary supplement) as a possible treatment. Condition(s) listed: Crohn's Disease.
Participants are assigned to groups by chance (randomized).
It is single-blind: participants do not know which group they are in.
Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.
Who can join
- Ages 6 to 17
- Any sex
Some of the main requirements, copied from the record:
- 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) despite anti-inflammatory…
- 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
Plus 2 more requirement(s). There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 120 participants are expected to take part.
- Start date: 2022-09-26.
- Main results expected around 2026-11 (estimate from the record).
- 4 study sites listed (4 marked recruiting) in France.
Main thing being measured
- Relapse from randomization until M12 (12 months)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Crohn's Disease |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
| Collaborators | MICALIS Institute; URC-CIC Paris Descartes Necker Cochin |
| Enrollment | 120 (estimated) |
| Start date | 2022-09-26 |
| Primary completion (est.) | 2026-11 |
| First posted | 2021-03-02 |
| Last updated | 2026-03-27 |
| Official title | Randomized Trial for Unstable Pediatric Crohn's Disease Patients Comparing the Use of Crohn's Disease Exclusion Diet (CDED) on Top of Standard Therapy Versus Standard Therapy Alone. |
| ClinicalTrials.gov ID | NCT04777656 |
Interventions
- Phase1 : CDED/Modulen™IBD® + Maintenance therapy (Dietary Supplement)
from D0 until M2: Phase 1 (2 months run-in phase with CDED protocol + maintenance therapy, with the exception of corticosteroid that have to be tapered and stopped until M2.) - Phase2 and 3 : (Dietary Supplement)
from M2 until M4 CDED phase 2 (introduction of a selected number of additional food). From M4 until end of the study CDED phase 3 (enlargement of number of additional foods and allowance of some initially excluded foods).
Full eligibility criteria (from the record)
Inclusion 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) despite anti-inflammatory (5-ASA and derivates), corticosteroids, immunomodulator (thiopurines or methotrexate) and/or biologic therapy (anti-TNF, anti-integrin anti-IL23 antibodies) * 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) Exclusion Criteria: * 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 interventional study
Locations (4)
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Femme mère enfant, CHU Lyon - Service Hépato-gastroentérologie et Nutrition pédiatrique | Bron | France | Recruiting |
| CHU Caen Normandie - Service de Gastroentérologie pédiatrique | Caen | France | Recruiting |
| Hôpital de la Timone, AP-HM - Service de Gastroentérologie pédiatrique | Marseille | France | Recruiting |
| Hôpital Necker-Enfants malades - Service de Gastroentérologie pédiatrique | Paris | France | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.