Clinical trial NCT02472457: Crohn Disease Exclusion Diet After Single Medication De-escalation
Official title: Biologic and Immunomodulator Withdrawal in Pediatric Crohn Disease With Deep Clinical Remission Using the Crohn Disease Exclusion Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn Disease
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Wolfson Medical Center
First posted: 2015-06-15
Enrollment: 19
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Sustained Relapse-free Remission
timeFrame: At 52 weeks following enrollment
Secondary outcomes:
measure: Time-to-relapse
timeFrame: Up to 104 weeks
measure: Microbial Composition of Gastrointestinal Tract (Types and Quantities of Microorganisms)
timeFrame: 6 weeks
measure: Microbial Composition of Gastrointestinal Tract (Types and Quantities of Microorganisms)
timeFrame: 52 weeks
Other outcomes:
measure: Dietary Compliance
timeFrame: Up to 52 weeks
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Ronen Stein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sigall-Boneh R, Pfeffer-Gik T, Segal I, Zangen T, Boaz M, Levine A. Partial enteral nutrition with a Crohn's disease exclusion diet is effective for induction of remission in children and young adults with Crohn's disease. Inflamm Bowel Dis. 2014 Aug;20(8):1353-60. doi: 10.1097/MIB.0000000000000110.