Crohn Disease Exclusion Diet After Single Medication De-escalation (CEASE)

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Crohn Disease

Treatments: Other: Crohn Disease Exclusion Diet; Other: Free Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02472457

14-011628

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 10 to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups, including a placebo group

Free Diet

Placebo Comparator group

Description:

No dietary restrictions

Treatment:

Other: Free Diet

Crohn Disease Exclusion Diet

Active Comparator group

Description:

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

Treatment:

Other: Crohn Disease Exclusion Diet