The Challenge Study: A Dietary Personalization Protocol for Patients With Crohn's Disease and Deep Remission
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|ClinicalTrials.gov Identifier: NCT02930564|
Recruitment Status : Recruiting
First Posted : October 12, 2016
Last Update Posted : February 17, 2021
The Challenge study is a prospective, open label, pilot trial in patients in deep remission on dietary maintenance therapy.
The purpose of this study is to determine whether they can consume some of the products that were eliminated from their diet, named the Crohn's Disease Exclusion Diet (CDED), and to evaluate if low dose exposure is harmful.
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Other: CDED + milk fat and gluten||Not Applicable|
The investigators have previously hypothesized that Crohn's disease may occur via a sequence of events involving dysbiosis and genetically determined or environmentally acquired defects in innate immunity, and have further hypothesized that the mechanism of EEN for induction of remission acts by reducing exposure to dietary components that may cause an acquired bacterial clearance defect or generate dysbiosis.
Based on this premise, the investigators developed a new exclusion diet. This diet, named the Crohn's Disease Exclusion Diet (CDED) reduces exposure to all the components identified in rodent models as well as two components that are highly suspect but have not been investigated in models. This diet was evaluated for induction of remission through week 12 and succeeded in inducing remission in 70% of 47 selected patients.
The investigators have now progressed to three randomized controlled trials to evaluate the diet in different populations with different disease severity, and the results from the first RCT demonstrate a high remission rate in the CDED arm. However , to date the investigators have used the same diet for all patients. The investigators are now encountering patients on the diet in deep remission, but the investigators do not know if they can consume some of the products ( such as milk fat and gluten) that were eliminated. The investigators therefore are starting to challenge our patients in deep remission with low dose exposure to evaluate if low dose exposure is harmful. The investigators wish to document this and obtain stool samples for calprotetctin and microbiome to investigate these patients at a microbiological level as well.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Challenge Study: A Dietary Personalization Protocol for Patients With Crohn's Disease and Deep Remission|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: a milk fat or gluten challenge
patients will regress to the first stage diet with either a milk fat /emulsifier or a gluten/emulsifier challenge over 7 days.
Other: CDED + milk fat and gluten
CDED phase 1- induction phase a milk fat /emulsifier challenge (one scoop of ice cream and one slice of yellow processed cheese every day in the evening over 7 days), or a gluten/emulsifier challenge ( 3-4 slices of bread)
Other Name: Crohn's Disease Exclusion Diet (CDED)
- number of patients with calprotetctin elevation [ Time Frame: day 14 or 21 ]
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): NCT02930564
|Contact: Arie Levine, MDfirstname.lastname@example.org|
|Study Chair:||Arie Levine, MD||Pediatric Gastroenterology and Nutrition Unit, The E. Wolfson MC, Tel-Aviv University, Holon, Israel|