Crohn Disease Exclusion Diet After Single Medication De-escalation (CEASE)
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ClinicalTrials.gov Identifier: NCT02472457 |
Recruitment Status :
Completed
First Posted : June 15, 2015
Results First Posted : May 27, 2020
Last Update Posted : October 20, 2020
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Condition or disease | Intervention/treatment | Phase |
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Crohn Disease | Other: Crohn Disease Exclusion Diet Other: Free Diet | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 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 |
Actual Primary Completion Date : | May 2019 |
Actual Study Completion Date : | September 2020 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Free Diet
No dietary restrictions
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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.
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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. |
- 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
- 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
- Dietary Compliance [ Time Frame: Up to 52 weeks ]Using modified Medication Adherence Rating Scale (MARS) questionnaire

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

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
United States, Pennsylvania | |
The Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Ronen Stein, MD | Children's Hospital of Philadelphia |
Documents provided by Children's Hospital of Philadelphia:
Responsible Party: | Children's Hospital of Philadelphia |
ClinicalTrials.gov Identifier: | NCT02472457 |
Other Study ID Numbers: |
14-011628 |
First Posted: | June 15, 2015 Key Record Dates |
Results First Posted: | May 27, 2020 |
Last Update Posted: | October 20, 2020 |
Last Verified: | September 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |