Cyclic Exclusive Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      The purpose of this study is to compare the rate of first relapse at 12 months between
      maintenance therapy with cyclic exclusive enteral nutrition (EEN) (at least 100% daily
      calories) and maintenance therapy with supplementary enteral nutritional support (25% daily
      calories).
    

Detailed description: 
      Enteral nutrition (EN) is a highly efficacious treatment option for Crohn's disease (CD). In
      children, exclusive EN is considered first choice therapy to induce remission in pediatric
      CD, as highlighted in the recent ESPGHAN-ECCO guidelines. Several meta-analyses showed that
      the anti-inflammatory potential of EEN is comparable to the effects of steroids. In addition,
      children with CD often have marked growth retardation and EEN is one of the most efficacious
      treatment options to induce catch-up growth in these patients. There is convincing data
      indicating that EN is highly efficacious when given on an exclusive basis, while the use of
      partial EN is markedly less effective to induce remission in active Crohn's disease as
      compared to exclusive EN. Recently, it was suggested that exclusive EN has a dominant effect
      on the intestinal microbiota, which contributes to the induction of remission. There exists
      several strategies to maintain remission in children with CD, but there is no clear consensus
      on which maintenance treatment to follow. There are some indicators to believe that enteral
      nutritional therapy might play also a significant role as maintenance therapy for CD. Given
      the fact that many centers use a top-down approach with the introduction of immunosuppressors
      and/or biologics at/or shortly after diagnosis, the investigators wanted to test the
      possibility of a treatment option to efficiently maintain remission with less (or no) side
      effects based on enteral nutrition to avoid the early use of immunosuppressors.

      It's a French multicenter, prospective, randomized study with PROBE (prospective randomized
      open blind end-point) evaluation. Randomization will be performed in a blinded and
      centralized manner, allocating patients to one of the two treatment groups :

        -  ARM A : Cyclic exclusive MODULEN IBD for 2 weeks every 8 weeks

        -  ARM B: MODULEN IBD supplementation (25% of caloric requirements) alone

      A Physician not involved in the study design and blinded to the treatment arm will perform
      the evaluation of the patients during each study visit.

      A total of four visits (including final visit) are scheduled for this trial over a period of
      12 months at a rhythm of every three months (+/- 2 weeks) for all patients. The study visit
      will happen during scheduled routine visits, necessary for the routine care of CD patients.
      Each visit comprises a routine clinical evaluation. The assessment of maintenance of
      remission is particularly important (wPCDAI<12.5 points), a routine lab analysis including
      fecal calprotectin is required at each visit. In addition, all relevant medical or other
      events will be recorded. Only for patients who participate in the annex studies an additional
      stool sample (microbial analysis) is required. At M9 visit, follow-up endoscopy (M12+/-
      6weeks) and entero-MRI (M12+/- 6 weeks) will be programmed as part of the routine
      surveillance of patients on maintenance therapy, allowing to adjust treatment in the
      following if necessary. Compliance to treatment will be monitored by recordings of daily
      MODULEN IBD intake during 2 week periods on the E-system. A quality of life E-questionnaire
      will be filled out one day prior to each visit.
    

Intervention name(s): MODULEN IBD; MODULEN IBD
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 week ON / 6 weeks OFF treatment every 8 weeks covering at least 100% of daily caloric requirement (approx. 2-2.5L/day).; 25% of daily caloric requirements, approx. 500mL/day
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crohn's disease,; pediatric GETAID (Therapeutic study group of inflammatory bowel diseases of the child),; enteral nutrition,; randomized multicenter study