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

Biologic and Immunomodulator Withdrawal in Pediatric Crohn Disease With Deep Clinical Remission Using the Crohn Disease Exclusion Diet

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.

Study Overview

• Status: Completed
• Conditions: Crohn Disease
• Intervention / Treatment: Other: Free Diet; Other: Crohn Disease Exclusion 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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Free Diet; No dietary restrictions	Other: Free Diet; This diet contains no restrictions.; Other Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustained Relapse-free Remission	Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin	At 52 weeks following enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-to-relapse	Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin	Up to 104 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 6 weeks	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	52 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary Compliance	Using modified Medication Adherence Rating Scale (MARS) questionnaire	Up to 52 weeks

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: Wolfson Medical Center
• Investigators: Principal Investigator: Ronen Stein, MD, Children's Hospital of Philadelphia

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: June 10, 2015
• First Submitted That Met QC Criteria: June 11, 2015
• First Posted (Estimate): June 15, 2015

Study Record Updates

• Last Update Posted (Actual): October 20, 2020
• Last Update Submitted That Met QC Criteria: September 29, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 14-011628

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No