The Challenge Study: A Dietary Personalization Protocol for Patients With Crohn's Disease and Deep Remission
Primary Purpose
Crohn's Disease
Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
CDED + milk fat and gluten
Sponsored by
About this trial
This is an interventional other trial for Crohn's Disease
Eligibility Criteria
Inclusion Criteria:
- Established diagnosis of Crohn's disease.
- Patients in sustained remission with PCDAI 0 > 6 months
- Ages 8-20
- Normal CRP (CRP<0.5), normal Calprotectin (<100)
- Patients with uncomplicated disease
- Signed informed consent
Exclusion Criteria:
- Patients with active disease (PCDAI >10)
- Pregnancy
- Patients with complicated disease (B2, B3)
- Patients with recent onset use of an immunomodulator <12 weeks, or dose change in past 12 weeks.
- Patients with current use of biologics.
- Elevated CRP or Calprotetcin>100 at screening.
Sites / Locations
- Wolfson Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
a milk fat or gluten challenge
Arm Description
patients will regress to the first stage diet with either a milk fat /emulsifier or a gluten/emulsifier challenge over 7 days.
Outcomes
Primary Outcome Measures
number of patients with calprotetctin elevation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02930564
Brief Title
The Challenge Study: A Dietary Personalization Protocol for Patients With Crohn's Disease and Deep Remission
Official Title
The Challenge Study: A Dietary Personalization Protocol for Patients With Crohn's Disease and Deep Remission
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
It is not possible to continue the study
Study Start Date
January 2017 (Actual)
Primary Completion Date
May 29, 2022 (Actual)
Study Completion Date
May 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wolfson Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
a milk fat or gluten challenge
Arm Type
Experimental
Arm Description
patients will regress to the first stage diet with either a milk fat /emulsifier or a gluten/emulsifier challenge over 7 days.
Intervention Type
Other
Intervention Name(s)
CDED + milk fat and gluten
Other Intervention Name(s)
Crohn's Disease Exclusion Diet (CDED)
Intervention Description
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)
Primary Outcome Measure Information:
Title
number of patients with calprotetctin elevation
Time Frame
day 14 or 21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Established diagnosis of Crohn's disease.
Patients in sustained remission with PCDAI 0 > 6 months
Ages 8-20
Normal CRP (CRP<0.5), normal Calprotectin (<100)
Patients with uncomplicated disease
Signed informed consent
Exclusion Criteria:
Patients with active disease (PCDAI >10)
Pregnancy
Patients with complicated disease (B2, B3)
Patients with recent onset use of an immunomodulator <12 weeks, or dose change in past 12 weeks.
Patients with current use of biologics.
Elevated CRP or Calprotetcin>100 at screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arie Levine, MD
Organizational Affiliation
Pediatric Gastroenterology and Nutrition Unit, The E. Wolfson MC, Tel-Aviv University, Holon, Israel
Official's Role
Study Chair
Facility Information:
Facility Name
Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Challenge Study: A Dietary Personalization Protocol for Patients With Crohn's Disease and Deep Remission
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