Pilot Study of Partial Enteral Nutrition With a Unique Diet for the Treatment of Adult Patients With Crohn's Disease (CDED-ADULTS)
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|ClinicalTrials.gov Identifier: NCT02231814|
Recruitment Status : Recruiting
First Posted : September 4, 2014
Last Update Posted : September 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Dietary Supplement: Crohns Disease Exclusion Diet + PEN Other: Crohns Disease Exclusion Diet||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dietary Therapy Using Partial Enteral Nutrition and the Crohn's Disease Exclusion Diet (CDED) for Induction and Maintenance of Remission in Mild to Moderate Crohn's Disease in Adults- A Pilot Study|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Group 1
Crohn's Disease Exclusion Diet+Partial Enteral Nutrition (PEN): Crohns Disease Exclusion Diet + PEN
Dietary Supplement: Crohns Disease Exclusion Diet + PEN
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.
Other Name: CDED + Liquid dietary formula
Experimental: Group 2
Crohn's Disease Exclusion Diet alone with a calcium supplement
Other: Crohns Disease Exclusion Diet
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 Name: CDED
- Clinical remission defined as Harvey Bradshaw Index (HBI)<5 [ Time Frame: Week 6 ]
- Steroid free remission [ Time Frame: Week 6, 12 and 24. ]
- Mucosal healing- Normal colonoscopy or normal MRE with normal calprotectin [ 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02231814
|Wolfson Medical Center||Recruiting|
|Contact: Arie Levine, MD +972-35028878 firstname.lastname@example.org|
|Principal Investigator: Arie Levine, MD|
|Rabin Medical Center||Recruiting|
|Petach Tikva, Israel|
|Contact: Keren Zonensain email@example.com|
|Principal Investigator: Iris Dotan, Professor|
|Principal Investigator: Henit Yanai, MD|
|Tel Aviv Sourasky Medical Center||Recruiting|
|Tel Aviv, Israel|
|Contact: Naomi Fliss, PhD firstname.lastname@example.org|
|Principal Investigator: Nitzan Maharshak, MD|
|Principal Investigator:||Arie Levine, MD||Wolfson Medical Center|
|Principal Investigator:||Iris Dotan, MD||Tel Aviv Medical Center|
|Principal Investigator:||Irit Hermesh, MD||Rambam Medical Center,Haifa|