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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
Sponsor:
Information provided by (Responsible Party):
Prof. Arie Levine, Wolfson Medical Center

Brief Summary:

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. number of patients with calprotetctin elevation [ Time Frame: day 14 or 21 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Established diagnosis of Crohn's disease.
  2. Patients in sustained remission with PCDAI 0 > 6 months
  3. Ages 8-20
  4. Normal CRP (CRP<0.5), normal Calprotectin (<100)
  5. Patients with uncomplicated disease
  6. Signed informed consent

Exclusion Criteria:

  1. Patients with active disease (PCDAI >10)
  2. Pregnancy
  3. Patients with complicated disease (B2, B3)
  4. Patients with recent onset use of an immunomodulator <12 weeks, or dose change in past 12 weeks.
  5. Patients with current use of biologics.
  6. Elevated CRP or Calprotetcin>100 at screening.

Information from the National Library of Medicine

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


Contacts
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Contact: Arie Levine, MD 972-3-5028808 alevine@wolfson.health.gov.il

Locations
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Israel
Wolfson Medical Center Recruiting
Holon, Israel, 58100
Contact: Arie Levine, MD    972 35028838    arie.levine.dr@gmail.com   
Contact: Noa Cohen    972 35028838    ibd.noa@gmail.com   
Principal Investigator: Arie Levine, MD         
Sponsors and Collaborators
Wolfson Medical Center
Investigators
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Study Chair: Arie Levine, MD Pediatric Gastroenterology and Nutrition Unit, The E. Wolfson MC, Tel-Aviv University, Holon, Israel
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Responsible Party: Prof. Arie Levine, Prof, Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT02930564    
Other Study ID Numbers: 0186-16-WOMC
First Posted: October 12, 2016    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases