NCT02472457

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 27, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

October 20, 2020

Status Verified

September 1, 2020

Enrollment Period

3.8 years

First QC Date

June 10, 2015

Results QC Date

May 11, 2020

Last Update Submit

September 29, 2020

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Time-to-relapse

    Up to 104 weeks

  • Microbial Composition of Gastrointestinal Tract (Types and Quantities of Microorganisms)

    6 weeks

  • Microbial Composition of Gastrointestinal Tract (Types and Quantities of Microorganisms)

    52 weeks

Other Outcomes (1)

  • Dietary Compliance

    Up to 52 weeks

Study Arms (2)

Free Diet

PLACEBO COMPARATOR

No dietary restrictions

Other: Free Diet

Crohn Disease Exclusion Diet

ACTIVE COMPARATOR

The CDED is a palatable diet that excludes foods suspected to have a role in intestinal inflammation.

Other: Crohn Disease Exclusion Diet

Interventions

Crohn Disease Exclusion DietOTHER

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.

Crohn Disease Exclusion Diet
Free DietOTHER

This diet contains no restrictions.

Also known as: Placebo
Free Diet

Eligibility Criteria

Age10 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • 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.

    PMID: 24983973BACKGROUND

  • Stein R, Daniel SG, Baldassano RN, Feigenbaum K, Kachelries K, Sigall-Boneh R, Weston S, Levine A, Bittinger K. Outcomes and Predictors of Sustained Remission After Drug Withdrawal in Pediatric Crohn Disease. J Pediatr Gastroenterol Nutr. 2022 Nov 1;75(5):608-615. doi: 10.1097/MPG.0000000000003589. Epub 2022 Aug 17.

    PMID: 35976282DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Results Point of Contact

Title
Ronen Stein, MD
Organization
The Children's Hospital of Philadelphia
ibdresearch@email.chop.edu
215-590-7801

Study Officials

  • Ronen Stein, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2015

First Posted

June 15, 2015

Study Start

August 1, 2015

Primary Completion

May 1, 2019

Study Completion

September 1, 2020

Last Updated

October 20, 2020

Results First Posted

May 27, 2020

Record last verified: 2020-09

Locations

US(1)