Crohn Disease Exclusion Diet After Single Medication De-escalation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2020-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients.

NCT04777656

Crohn's Disease

RECRUITING PHASE3

The Crohn's Disease Exclusion Diet With Partial Enteral Nutrition or Alone in Adult Patients With Crohn's Disease

NCT02231814

Crohn's Disease

COMPLETED NA

The Challenge Study: A Dietary Personalization Protocol for Patients With Crohn's Disease and Deep Remission

NCT02930564

Crohn's Disease

TERMINATED NA

Top-down Infliximab Study in Kids With Crohn's Disease

NCT02517684

Crohn's Disease

COMPLETED PHASE4

Growth Hormone and Exclusion Diet Therapy in Juvenile Crohn's Disease

NCT01647412

Crohn's Disease

WITHDRAWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Crohn Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Free Diet

No dietary restrictions

Group Type PLACEBO_COMPARATOR

Free Diet

Intervention Type OTHER

This diet contains no restrictions.

Crohn Disease Exclusion Diet

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

Group Type ACTIVE_COMPARATOR

Crohn Disease Exclusion Diet

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Free Diet

This diet contains no restrictions.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Placebo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No