The Crohn's Disease Exclusion Diet With Partial Enteral Nutrition or Alone in Adult Patients With Crohn's Disease
- Conditions
- Crohn's Disease
- Interventions
- Dietary Supplement: Crohns Disease Exclusion Diet + PENOther: Crohns Disease Exclusion Diet
- Registration Number
- NCT02231814
- Lead Sponsor
- Prof. Arie Levine
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Crohns Disease Exclusion Diet + PEN Crohn's Disease Exclusion Diet+Partial Enteral Nutrition (PEN): Crohns Disease Exclusion Diet + PEN Group 2 Crohns Disease Exclusion Diet Crohn's Disease Exclusion Diet alone with a calcium supplement
- Primary Outcome Measures
Name Time Method Clinical remission defined as Harvey Bradshaw Index (HBI)<5 Week 6
- Secondary Outcome Measures
Name Time Method Steroid free remission between groups Week 6, 12 and 24. Changes in mean C-Reactive Protein (CRP) Weeks 6, 12 and 24. Change in mean fecal calprotectin Week 6, 12 and 24 Mucosal healing Week 24-26
Trial Locations
- Locations (4)
Haemek
🇮🇱Afula, Israel
Rabin Medical Center
🇮🇱Petach Tikva, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Wolfson Medical Center
🇮🇱Holon, Israel