Crohn Disease Exclusion Diet After Single Medication De-escalation

Not Applicable

Completed

• Conditions: Crohn Disease
• Interventions: Other: Free Diet; Other: Crohn Disease Exclusion Diet

• Registration Number: NCT02472457
• Lead Sponsor: Children's Hospital of Philadelphia

Brief 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.

Detailed Description

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 Timeline

• Study First Submitted: 2015-06-10
• Study First Submitted QC: 2015-06-11
• Study First Posted: 2015-06-15
• Study Start: 2015-08
• Primary Completion: 2019-05
• Results First Submitted: 2020-05-11
• Results First Submitted QC: 2020-05-11
• Results First Posted: 2020-05-27
• Status Verified: 2020-09
• Study Completion: 2020-09
• Last Update Submitted: 2020-09-29
• Last Update Posted: 2020-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Free Diet	Free Diet	No dietary restrictions
Crohn Disease Exclusion Diet	Crohn Disease Exclusion Diet	The CDED is a palatable diet that excludes foods suspected to have a role in intestinal inflammation.

Primary Outcome Measures

Name	Time	Method
Sustained Relapse-free Remission	At 52 weeks following enrollment	Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States