Crohn Disease
Conditions
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.
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.
Interventions
OTHERCrohn 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.
OTHERFree Diet
This diet contains no restrictions.
Sponsors
Wolfson Medical Center
Children's Hospital of Philadelphia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 21 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Relapse-free Remission | At 52 weeks following enrollment | Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-to-relapse | Up to 104 weeks | Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin |
| Microbial Composition of Gastrointestinal Tract (Types and Quantities of Microorganisms) | 6 weeks | Change in the microbial composition of the stool, mouth and rectum from baseline to 6 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dietary Compliance | Up to 52 weeks | Using modified Medication Adherence Rating Scale (MARS) questionnaire |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Free Diet No dietary restrictions
Free Diet: This diet contains no restrictions. | 8 |
| Crohn Disease Exclusion Diet The CDED is a palatable diet that excludes foods suspected to have a role in intestinal inflammation.
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. | 10 |
| Total | 18 |
Baseline characteristics
| Characteristic | Free Diet | Crohn Disease Exclusion Diet | Total |
|---|---|---|---|
| Age, Continuous | 16.5 years STANDARD_DEVIATION 3.6 | 16.0 years STANDARD_DEVIATION 2.2 | 16.2 years STANDARD_DEVIATION 2.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 10 Participants | 18 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Israel | 1 participants | 4 participants | 5 participants |
| Region of Enrollment United States | 7 participants | 6 participants | 13 participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 10 |
| other Total, other adverse events | 0 / 8 | 0 / 10 |
| serious Total, serious adverse events | 0 / 8 | 0 / 10 |
Outcome results
Primary
Sustained Relapse-free Remission
Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin
Time frame: At 52 weeks following enrollment
Population: 1 participant in the free diet group followed the specific carbohydrate diet and was in remission at 52 weeks. 1 participant in the CDED group withdrew prior to 52 weeks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Free Diet | Sustained Relapse-free Remission | 6 Participants |
| Crohn Disease Exclusion Diet | Sustained Relapse-free Remission | 5 Participants |
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
Time frame: 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
Time frame: 52 weeks
Secondary
Time-to-relapse
Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin
Time frame: Up to 104 weeks
Other Pre-specified
Dietary Compliance
Using modified Medication Adherence Rating Scale (MARS) questionnaire
Time frame: Up to 52 weeks