CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 19 enrolled
Drug / intervention
Crohn Disease Exclusion Diet +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02472457
NCT02472457N/ACompleted
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Biologic and Immunomodulator Withdrawal in Pediatric Crohn Disease With Deep Clinical Remission Using the Crohn Disease Exclusion Diet

Children's Hospital of Philadelphia·interventional·Posted Jun 15, 2015·Updated Oct 20, 2020

In Brief

A clinical study evaluating Crohn Disease Exclusion Diet and Free Diet for Crohn Disease. Completed, enrolled 19 participants across 1 site.

Detailed Summary

The primary objective of this study is to determine whether pediatric Crohn Disease (CD) patients in long-standing remission remain in remission longer after stopping medications if they follow the Crohn's Disease Exclusion Diet (CDED). The hypothesis is that subjects on the CDED will have longer time-to-relapse as opposed to those on an unrestricted diet.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn Disease
CountriesUnited States
CollaboratorsWolfson Medical Center

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 15, 2015
Enrollment StartAug 1, 2015
Primary CompletionMay 1, 2019
Study CompletionSep 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 11.0 years ago

Interventions

Crohn Disease Exclusion Dietother

The CDED is divided into 4 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase I, and weeks 25-52 maintenance phase II.

Free Dietother

This diet contains no restrictions.