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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):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Crohn Disease Other: Crohn Disease Exclusion Diet Other: Free Diet

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biologic and Immunomodulator Withdrawal in Pediatric Crohn Disease With Deep Clinical Remission Using the Crohn Disease Exclusion Diet
Study Start Date : June 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Free Diet
No dietary restrictions
Other: Free Diet
This diet contains no restrictions.
Other Name: Placebo
Active Comparator: Crohn Disease Exclusion Diet
The CDED is a palatable diet that excludes foods suspected to have a role in intestinal inflammation.
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.


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Time-to-relapse [ Time Frame: Up to 104 weeks ]
    Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin

  2. 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

  3. 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


Other Outcome Measures:
  1. Dietary Compliance [ Time Frame: Up to 52 weeks ]
    Using modified Medication Adherence Rating Scale (MARS) questionnaire


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02472457


Contacts
Contact: Ronen Stein, MD 215-590-7801 ibdresearch@email.chop.edu
Contact: Robert Baldassano, MD 267-426-5123 ibdresearch@email.chop.edu

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Ronen Stein, MD    215-590-7801    ibdresearch@email.chop.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
Wolfson Medical Center
Investigators
Principal Investigator: Robert Baldassano, MD Children's Hospital of Philadelphia
More Information

Publications:
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02472457     History of Changes
Other Study ID Numbers: 14-011628
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases