Have you or your loved ones been diagnosed with crohn disease?

You may be eligible to participate in a crohn disease clinical trial.

Have you or your loved ones been diagnosed with crohn disease? You may be eligible to participate in a crohn disease clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Crohn Disease Clinical Trial in Philadelphia PA

NCT02472457 | Interventional

Have you or your loved ones been diagnosed with crohn disease?

You may be eligible to participate in a crohn disease clinical trial.

Have you or your loved ones been diagnosed with crohn disease? You may be eligible to participate in a crohn disease clinical trial.

Completed

Male & Female

10 - 21

Years old

This study has recruited 19 Participants

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.

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Details for the study

Brief Title

Crohn Disease Exclusion Diet After Single Medication De-escalation

Official Title

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

Brief Summary

The primary objective of this study is to determine whether pediatric Crohn Disease (CD)<br /> patients in long-standing remission remain in remission longer after stopping medications if<br /> they follow the Crohn's Disease Exclusion Diet (CDED). The hypothesis is that subjects on the<br /> CDED will have longer time-to-relapse as opposed to those on an unrestricted 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.

Treatments and/or Procedures

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

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

Other

Dietary Compliance

Using modified Medication Adherence Rating Scale (MARS) questionnaire

Up to 52 weeks

Study 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.