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You will receive

Study-related treatment at no cost


To qualify, you must be

Male or Female

10 - 21

Years Old


This is where the study procedures will take place

Travel expenses may be reimbursed


Showing 1 of 1 available location(s)
The Children's Hospital of Philadelphia Claim this site

Recruiting United States, Philadelphia Pennsylvania

Study Details

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Study Conditions

About This Condition


Who can participate?

Ideal candidates should meet the following criteria

  • Colonoscopy during the preceding 3 months with complete mucosal healing or only few aphthous ulcerations located in one segment
  • Steroid-free Remission (Pediatric Crohn Disease Activity Index Score <10 without the height component) for at least 12 months prior to enrollment
  • Normal Growth Velocity, or Tanner 5
  • 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.
  • Parental/guardian permission (informed consent) and, if appropriate, child assent.
  • Stool calprotectin <250µg/g during the preceding 3 months

Reasons you may not be a good fit

  • Those subjects who in the judgment of the investigative team are unable to complete the study endpoints.
  • Discontinuation of biologic or immunomodulator therapy by the subject without the approval of the primary gastroenterologist.


About This Study

Name

Crohn Disease Exclusion Diet After Single Medication De escalation

Status

Recruiting

ID

NCT02472457

Phase

NA

Type

Interventional

Summary

Biologic and Immunomodulator Withdrawal in Pediatric Crohn Disease With Deep Clinical Remission Using the Crohn Disease Exclusion Diet

Purpose

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.

Details

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Study Interventions
Other(s)

Crohn disease exclusion diet

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 diet

This diet contains no restrictions.



What will be monitored/measured (Outcomes)

Sustained relapse-free remission

At 52 weeks following enrollment

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


Time-to-relapse

Up to 104 weeks

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


Microbial composition of gastrointestinal tract (types and quantities of microorganisms)

6 weeks

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


Microbial composition of gastrointestinal tract (types and quantities of microorganisms)

52 weeks

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


Dietary Compliance

Up to 52 weeks

Using modified Medication Adherence Rating Scale (MARS) questionnaire



This Study is Sponsored By


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