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

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ClinicalTrials.gov Identifier: NCT02472457
Recruitment Status : Active, not recruiting
First Posted : June 15, 2015
Last Update Posted : November 9, 2018
Sponsor:
Collaborator:
Wolfson Medical Center
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Crohn Disease Other: Crohn Disease Exclusion Diet Other: Free Diet Not Applicable

Detailed Description:
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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 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
Actual Study Start Date : August 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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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
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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
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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
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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


Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Wolfson Medical Center
Investigators
Principal Investigator: Ronen Stein, MD Children's Hospital of Philadelphia
More Information
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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 9, 2018
Last Verified: November 2018

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