Crohn Disease Exclusion Diet After Single Medication De-escalation

Crohn Disease Clinical Trial

— CEASE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02472457
• Other study ID #: 14-011628
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: September 2020

Study information

• Verified date: September 2020
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 2020
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease

Intervention

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.
• Free Diet
This diet contains no restrictions.

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Wolfson Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dietary Compliance	Using modified Medication Adherence Rating Scale (MARS) questionnaire	Up to 52 weeks
Primary	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	Time-to-relapse	Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin	Up to 104 weeks
Secondary	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
Secondary	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