Diet for Induction and Maintenance of Remission and Re-biosis in Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      The modified-Exclusive Enteral Nutrition (mEEN) is an open label randomized controlled trial
      in mild to severe Crohn's Disease patients. The purpose of this study is to determine whether
      induction of remission and maintenance of remission can be achieved with a new dietary
      strategy that involves only 2 weeks of Exclusive Enteral Nutrition (EEN) with Modulen and 12
      weeks of an exclusion diet involving selected table foods. This novel approach will be
      compared to the gold standard dietary regime involving 8 weeks of EEN.
    

Detailed description: 
      Rational: Exclusive enteral nutrition (EEN) is an established but difficult to perform method
      for induction of remission and cannot be used for maintenance of remission. It entails
      drinking only liquid formula for 8 weeks. Refusal to use or to adhere to this therapy is not
      uncommon and leads to use of other non- dietary strategies in children including steroids and
      immunosuppression. The Crohn's Disease Exclusion Diet (CDED) with partial enteral nutrition
      has been shown to be effective for children with mild to moderate disease. The investigators
      have developed a maintenance strategy using the CDED.

      Objectives: To prove that induction of remission and maintenance of remission can be achieved
      with a new dietary strategy that involves only 2 weeks of EEN with Modulen and 12 weeks of an
      exclusion diet involving selected table foods.

      Methods: Open label randomized controlled pilot trial comparing two weeks of EEN followed by
      the CDED and Partial Enteral Nutrition (PEN), to 8 weeks of EEN followed by PEN with free
      diet. The study will include a control group of healthy children for microbiome studies.

      Population: Age 8-18 years with mild to severe active Crohn's disease defined as 15≤Pediatric
      Crohn's Disease Activity Index (PCDAI)<47.5.

      Time frame: The induction of remission phase will last 8 weeks followed by maintenance phase
      for a period of 24 weeks.

      Expected outcomes and significance: If this method proves to be equivalent to EEN, the
      duration of use of EEN will be only two weeks, allowing more patients access to dietary
      therapy. More importantly, this study will also evaluate two maintenance strategies and will
      be the first to evaluate re-biosis.
    

Intervention name(s): Modified Exclusive Enteral Nutrition; Crohn's Disease Exclusion Diet; Partial Enteral Nutrition; Standard Exclusive Enteral Nutrition
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Two weeks of Exclusive Enteral Nutrition with Modulen; a limited whole food diet; 25-50% of Energy from formula; 8 weeks of Exclusive Enteral Nutrition
Other intervention name(s): Modulen, Nestle; CDED; Modulen, Nestle; Modulen, Nestle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crohn's Disease; Pediatric; Exclusive Enteral Nutrition; Diet; Microbiome