N/A
Completed N=19
Crohn Disease Exclusion Diet After Single Medication De-escalation
Crohn Disease
Source: ClinicalTrials.gov NCT02472457 ↗
Enrolled (actual)
19
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Sustained Relapse-free Remission — 6; 5 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sustained Relapse-free Remission |
6; 5 | — |
| SECONDARY Time-to-relapse |
— | — |
| SECONDARY Microbial Composition of Gastrointestinal Tract (Types and Quantities of Microorganisms) |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT02472457). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.