The Crohn's Disease Exclusion Diet With Partial Enteral Nutrition or Alone in Adult Patients With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      This study will evaluate a novel diet for adult crohn's disease patients (The Crohn's Disease
      Exclusion Diet - CDED). Half of the patients in this study will receive the CDED alone while
      the other half will receive the CDED and a liquid diet formula, for 24 weeks.
    

Detailed description: 
      Environmental factors, the microbiome (bacteria in our gut) and innate immunity all play a
      role in the pathogenesis of Crohn's disease .Exclusive enteral nutrition (EEN) was found to
      be effective for inducing remission in active pediatric Crohn's disease, while Partial
      Enteral Nutrition (PEN) with free diet was not; suggesting that the mechanism of EEN depends
      on exclusion of dietary components. Dietary factors may play a role in the pathogenesis of
      the disease, and maybe an important under-investigated therapeutic target.

      "The Crohn's Disease Exclusion Diet" (CDED) is a palatable diet excluding components
      suspected to interfere with the bacteria in our gut or impair immune mechanisms. Our group
      previously evaluated 47 patients using the Crohn's disease Exclusion Diet + 50% Polymeric
      formula for 6 weeks, and demonstrated a 78% response rate and 70% disease remission rate
      using stringent criteria. This was accompanied by a highly significant reduction in markers
      for inflammation (C-reactive protein (CRP) and Erythrocyte Sedimentation Rate (ESR)), and
      normalization of CRP in 70% of those entering remission. Among these patients were 13 adults
      aged 19-32, the remission rate in these 13 patients was 69%, similar to the pediatric data.
      Importantly, 6/7 patients in this study who refused to drink formula and just used the diet
      achieved remission, suggesting that the exclusion and not partial enteral nutrition are
      responsible for the high remission rate. Our former study did not evaluate mucosal healing as
      an end point, since performing colonoscopies after 6- 12 weeks of therapy is neither ethical
      nor feasible in children.

      At present, data about nutritional therapy and this new dietary approach have been generated
      primarily in children, and this new diet has not been evaluated for early mucosal healing.
      The objectives of this pilot study are to generate data in adults, evaluate the diet over a
      longer period of time (24 weeks) and evaluate mucosal healing. The study is a prospective
      open label randomized controlled pilot trial in adults, with mild to moderate Crohn's disease
      who will receive the Crohn's Disease Exclusion Diet (CDED) for 24 weeks.

      If effective, this could enable use of a feasible, safe intervention for induction and
      maintenance of remission as a new therapy or as an adjunctive therapy with medical therapy.
    

Intervention name(s): Crohns Disease Exclusion Diet + PEN; Crohns Disease Exclusion Diet
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Patients will use the CDED for a 24 week period, coupled with 1000 m"l of polymeric formula (1 Kcal/m"L) for the first 6 weeks. For weeks 7 to 24 patients will use the CDED coupled with 600 ml formula and a calcium supplement. The CDED is divided into 3 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase.; Crohn's Disease Exclusion Diet alone with a calcium supplement during the study (0-24). The CDED is divided into 3 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase.
Other intervention name(s): CDED + Liquid dietary formula; CDED
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crohn's disease; Mild to moderate Crohn's Disease; Diet; Enteral Nutrition