Crohn Disease Exclusion Diet After Single Medication De-escalation

Children's Hospital of Philadelphia19 enrolled

Overview

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.

Crohn disease (CD) is an idiopathic, chronic, relapsing and remitting inflammatory condition of the gastrointestinal tract with a high risk for complications and need for surgical interventions, particularly in children. Immunomodulators and biologic therapies are effective at inducing and maintaining remission in pediatric CD, yet there is no proven strategy for reducing exposure to medications once sustained remission has been achieved. Diet has been proven to impact disease activity in CD and may allow for sustained drug-free remission. The primary objective of this study is to determine whether pediatric 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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Crohn Disease

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.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with a diagnosis of Crohn Disease using the Revised Porto criteria who will be withdrawing from biologic or immunomodulator monotherapy as part of clinical care. * Normal Growth Velocity, or Tanner 5 * Steroid-free Remission (Pediatric Crohn Disease Activity Index Score \<10 without the height component) for at least 12 months prior to enrollment * Colonoscopy during the preceding 3 months with complete mucosal healing or only few aphthous ulcerations located in one segment * Stool calprotectin \<250µg/g during the preceding 3 months * Parental/guardian permission (informed consent) and, if appropriate, child assent. Exclusion Criteria: * Discontinuation of biologic or immunomodulator therapy by the subject without the approval of the primary gastroenterologist. * Those subjects who in the judgment of the investigative team are unable to complete the study endpoints.

Locations (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Sustained Relapse-free Remission

Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin

Time frame: At 52 weeks following enrollment

Secondary Outcomes

Time-to-relapse

Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin

Time frame: Up to 104 weeks

Microbial Composition of Gastrointestinal Tract (Types and Quantities of Microorganisms)

Change in the microbial composition of the stool, mouth and rectum from baseline to 6 weeks

Time frame: 6 weeks

Microbial Composition of Gastrointestinal Tract (Types and Quantities of Microorganisms)

Change in the microbial composition of the stool, mouth and rectum from baseline to 52 weeks

Time frame: 52 weeks

Data from ClinicalTrials.gov

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