Crohn Disease Exclusion Diet After Single Medication De-escalation

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

Sponsors

Lead Sponsor: Children's Hospital of Philadelphia

Collaborator: Wolfson Medical Center

Source 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.

Overall Status Completed
Start Date 2015-08-01
Completion Date 2020-09-01
Primary Completion Date 2019-05-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Sustained Relapse-free Remission At 52 weeks following enrollment
Secondary Outcome
Measure Time Frame
Time-to-relapse Up to 104 weeks
Microbial Composition of Gastrointestinal Tract (Types and Quantities of Microorganisms) 6 weeks
Microbial Composition of Gastrointestinal Tract (Types and Quantities of Microorganisms) 52 weeks
Enrollment 19
Condition
Intervention

Intervention Type: Other

Intervention Name: Crohn Disease Exclusion Diet

Description: 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.

Arm Group Label: Crohn Disease Exclusion Diet

Intervention Type: Other

Intervention Name: Free Diet

Description: This diet contains no restrictions.

Arm Group Label: Free Diet

Other Name: Placebo

Eligibility

Criteria:

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.

Gender:

All

Minimum Age:

10 Years

Maximum Age:

21 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Ronen Stein, MD Principal Investigator Children's Hospital of Philadelphia
Location
Facility: The Children's Hospital of Philadelphia
Location Countries

United States

Verification Date

2020-09-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Free Diet

Type: Placebo Comparator

Description: No dietary restrictions

Label: Crohn Disease Exclusion Diet

Type: Active Comparator

Description: The CDED is a palatable diet that excludes foods suspected to have a role in intestinal inflammation.

Acronym CEASE
Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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