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

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ClinicalTrials.gov Identifier: NCT02472457
Recruitment Status : Recruiting
First Posted : June 15, 2015
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

June 10, 2015
June 15, 2015
November 6, 2017
June 2015
July 2018   (Final data collection date for primary outcome measure)
Sustained relapse-free remission [ Time Frame: At 52 weeks following enrollment ]
Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin
Same as current
Complete list of historical versions of study NCT02472457 on ClinicalTrials.gov Archive Site
  • Time-to-relapse [ Time Frame: Up to 104 weeks ]
    Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin
  • Microbial composition of gastrointestinal tract (types and quantities of microorganisms) [ Time Frame: 6 weeks ]
    Change in the microbial composition of the stool, mouth and rectum from baseline to 6 weeks
  • Microbial composition of gastrointestinal tract (types and quantities of microorganisms) [ Time Frame: 52 weeks ]
    Change in the microbial composition of the stool, mouth and rectum from baseline to 52 weeks
Same as current
Dietary Compliance [ Time Frame: Up to 52 weeks ]
Using modified Medication Adherence Rating Scale (MARS) questionnaire
Same as current
 
Crohn Disease Exclusion Diet After Single Medication De-escalation
Biologic and Immunomodulator Withdrawal in Pediatric Crohn Disease With Deep Clinical Remission Using the Crohn Disease Exclusion Diet
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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Crohn Disease
  • Other: Crohn Disease Exclusion Diet
    The CDED is divided into 4 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase I, and weeks 25-52 maintenance phase II.
  • Other: Free Diet
    This diet contains no restrictions.
    Other Name: Placebo
  • Placebo Comparator: Free Diet
    No dietary restrictions
    Intervention: Other: Free Diet
  • Active Comparator: Crohn Disease Exclusion Diet
    The CDED is a palatable diet that excludes foods suspected to have a role in intestinal inflammation.
    Intervention: Other: Crohn Disease Exclusion Diet
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
35
July 2019
July 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
10 Years to 21 Years   (Child, Adult)
No
Contact: Ronen Stein, MD 215-590-7801 ibdresearch@email.chop.edu
Contact: Robert Baldassano, MD 267-426-5123 ibdresearch@email.chop.edu
United States
 
 
NCT02472457
14-011628
No
Not Provided
Not Provided
Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Wolfson Medical Center
Principal Investigator: Robert Baldassano, MD Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP