An interventional study of Crohns Disease Exclusion Diet + PEN and Crohns Disease Exclusion Diet in Crohn's Disease, sponsored by Prof. Arie Levine. Completed at 4 sites in Israel. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-06-01.
Sponsored by Prof. Arie Levine · Not applicable, Interventional, and Treatment
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.
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 40 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Prof. Arie Levine is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria
Comments:
Patients with Celiac disease or Hashimoto Thyroiditis can be enrolled
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Crohn's Disease Exclusion Diet+Partial Enteral Nutrition (PEN): Crohns Disease Exclusion Diet + PEN
Dietary Supplement: Crohns Disease Exclusion Diet + PEN
Crohn's Disease Exclusion Diet alone with a calcium supplement
Other: Crohns Disease Exclusion Diet
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.
Also known as: CDED + Liquid dietary formula
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.
Also known as: CDED
Clinical remission defined as Harvey Bradshaw Index (HBI)<5
Time frame: Week 6
Steroid free remission between groups
Time frame: Week 6, 12 and 24.
Mucosal healing
Time frame: Week 24-26
Changes in mean C-Reactive Protein (CRP)
Time frame: Weeks 6, 12 and 24.
Change in mean fecal calprotectin
Time frame: Week 6, 12 and 24
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Prof. Arie Levine