Crohn Disease Exclusion Diet After Single Medication De-escalation

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.

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.