NCT02843100

Diet for Induction and Maintenance of Remission and Re-biosis in Crohn's Disease

Modified Exclusive Enteral Nutrition With the Crohn's Disease Exclusion Diet for Induction and Maintenance of Remission and Re-biosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Prof. Arie Levine · Other Government
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
OTHER	Modified Exclusive Enteral Nutrition	Two weeks of Exclusive Enteral Nutrition with Modulen
OTHER	Crohn's Disease Exclusion Diet	a limited whole food diet
OTHER	Partial Enteral Nutrition	25-50% of Energy from formula
OTHER	Standard Exclusive Enteral Nutrition	8 weeks of Exclusive Enteral Nutrition

Timeline

• Start date: 2018-04-10
• Primary completion: 2022-05-29
• Completion: 2022-05-29
• First posted: 2016-07-25
• Last updated: 2022-06-01

Locations

7 sites across 4 countries: Canada, Ireland, Israel, Spain