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

NCT02930564 | Terminated DMC

• 1 other identifier: 0186-16-WOMC
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• number of patients with calprotetctin elevation

  day 14 or 21

Study Arms (1)

a milk fat or gluten challenge

EXPERIMENTAL

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

Interventions

CDED + milk fat and gluten OTHER

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)

Also known as: Crohn's Disease Exclusion Diet (CDED)

a milk fat or gluten challenge

Eligibility Criteria

• Age: 8 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

Wolfson Medical Center

Holon, 58100, Israel

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Glutens

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Prolamins; Grain Proteins; Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Seed Storage Proteins

Study Officials

• Arie Levine, MD

  Pediatric Gastroenterology and Nutrition Unit, The E. Wolfson MC, Tel-Aviv University, Holon, Israel

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: October 9, 2016
• First Posted: October 12, 2016
• Study Start: January 1, 2017
• Primary Completion: May 29, 2022
• Study Completion: May 29, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

IL (1)