Crohn Disease Exclusion Diet After Single Medication De-escalation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Crohn Disease

Intervention / Treatment
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* Other: Crohn Disease Exclusion Diet
* Other: Free Diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Free Diet<br>No dietary restrictions | Other: Free Diet<br>* This diet contains no restrictions.<br>* Other names: Placebo;|
| Active Comparator: Crohn Disease Exclusion Diet<br>The CDED is a palatable diet that excludes foods suspected to have a role in intestinal inflammation. | Other: Crohn Disease Exclusion Diet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Relapse-free Remission | Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin | At 52 weeks following enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-relapse | Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin | 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 | 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 | 52 weeks |