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

• ClinicalTrials.gov Identifier: NCT02472457
• Recruitment Status: Completed
• First Posted: June 15, 2015
• Results First Posted: May 27, 2020
• Last Update Posted: October 20, 2020
• Sponsor: Children's Hospital of Philadelphia
• Collaborator: Wolfson Medical Center
• Information provided by (Responsible Party): Children's Hospital of Philadelphia

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.

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

• 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

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

• 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

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

  Study Documents (Full-Text)

Documents provided by Children's Hospital of Philadelphia:

Study Protocol and Statistical Analysis Plan  [PDF] May 10, 2019

More Information

Publications:

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.

• Responsible Party: Children's Hospital of Philadelphia
• ClinicalTrials.gov Identifier: NCT02472457
• Other Study ID Numbers: 14-011628
• First Posted: June 15, 2015
• 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

Additional relevant MeSH terms:

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases