Crohn Disease Exclusion Diet After Single Medication De-escalation

Completed · Not applicable · Has a placebo group

Conditions studied: Crohn Disease

In brief

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.

Key facts

Study ID

NCT02472457

Run by

Children's Hospital of Philadelphia

People needed

19

Starts

2015-08-01

Expected to finish

2020-09-01

Last updated by the study team

2020-10-20

Who can join

Age: 10 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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