The Challenge Study: A Dietary Personalization Protocol for Patients With Crohn's Disease and Deep Remission

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.

Study Overview

• Status: Terminated
• Conditions: Crohn's Disease
• Intervention / Treatment: Other: CDED + milk fat and gluten

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Holon, Israel, 58100
    • Wolfson Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Crohn's Disease Exclusion Diet (CDED)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of patients with calprotetctin elevation	day 14 or 21

Collaborators and Investigators

• Sponsor: Wolfson Medical Center
• Investigators: Study Chair: Arie Levine, MD, Pediatric Gastroenterology and Nutrition Unit, The E. Wolfson MC, Tel-Aviv University, Holon, Israel

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): May 29, 2022
• Study Completion (Actual): May 29, 2022

Study Registration Dates

• First Submitted: October 9, 2016
• First Submitted That Met QC Criteria: October 9, 2016
• First Posted (Estimate): October 12, 2016

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 29, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 0186-16-WOMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No