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

NCT02930564 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-06-01

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • Wolfson Medical Center

    lead OTHER_GOV

Principal Investigators

  • Arie Levine, MD · Pediatric Gastroenterology and Nutrition Unit, The E. Wolfson MC, Tel-Aviv University, Holon, Israel

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2022-05-29
Completion
2022-05-29

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02930564 on ClinicalTrials.gov