Crohn Disease Exclusion Diet After Single Medication De-escalation (CEASE)
Primary Purpose
Crohn Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Crohn Disease Exclusion Diet
Free Diet
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease
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.
Sites / Locations
- The Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Free Diet
Crohn Disease Exclusion Diet
Arm Description
No dietary restrictions
The CDED is a palatable diet that excludes foods suspected to have a role in intestinal inflammation.
Outcomes
Primary Outcome Measures
Sustained Relapse-free Remission
Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin
Secondary Outcome Measures
Time-to-relapse
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)
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)
Change in the microbial composition of the stool, mouth and rectum from baseline to 52 weeks
Full Information
NCT ID
NCT02472457
First Posted
June 10, 2015
Last Updated
September 29, 2020
Sponsor
Children's Hospital of Philadelphia
Collaborators
Wolfson Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02472457
Brief Title
Crohn Disease Exclusion Diet After Single Medication De-escalation
Acronym
CEASE
Official Title
Biologic and Immunomodulator Withdrawal in Pediatric Crohn Disease With Deep Clinical Remission Using the Crohn Disease Exclusion Diet
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
September 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
Wolfson Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Free Diet
Arm Type
Placebo Comparator
Arm Description
No dietary restrictions
Arm Title
Crohn Disease Exclusion Diet
Arm Type
Active Comparator
Arm Description
The CDED is a palatable diet that excludes foods suspected to have a role in intestinal inflammation.
Intervention Type
Other
Intervention Name(s)
Crohn Disease Exclusion Diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Free Diet
Other Intervention Name(s)
Placebo
Intervention Description
This diet contains no restrictions.
Primary Outcome Measure Information:
Title
Sustained Relapse-free Remission
Description
Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin
Time Frame
At 52 weeks following enrollment
Secondary Outcome Measure Information:
Title
Time-to-relapse
Description
Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin
Time Frame
Up to 104 weeks
Title
Microbial Composition of Gastrointestinal Tract (Types and Quantities of Microorganisms)
Description
Change in the microbial composition of the stool, mouth and rectum from baseline to 6 weeks
Time Frame
6 weeks
Title
Microbial Composition of Gastrointestinal Tract (Types and Quantities of Microorganisms)
Description
Change in the microbial composition of the stool, mouth and rectum from baseline to 52 weeks
Time Frame
52 weeks
Other Pre-specified Outcome Measures:
Title
Dietary Compliance
Description
Using modified Medication Adherence Rating Scale (MARS) questionnaire
Time Frame
Up to 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronen Stein, MD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24983973
Citation
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.
Results Reference
background
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Crohn Disease Exclusion Diet After Single Medication De-escalation
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