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| Name | Class |
|---|---|
| Wolfson Medical Center | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Free Diet | Placebo Comparator | No dietary restrictions |
|
| Crohn Disease Exclusion Diet | Active Comparator | The CDED is a palatable diet that excludes foods suspected to have a role in intestinal inflammation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crohn Disease Exclusion Diet | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Relapse-free Remission | Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin | At 52 weeks following enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-relapse | Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin | Up to 104 weeks |
| Microbial Composition of Gastrointestinal Tract (Types and Quantities of Microorganisms) |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary Compliance | Using modified Medication Adherence Rating Scale (MARS) questionnaire | Up to 52 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronen Stein, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24983973 | Background | 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. | |
| 35976282 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Free Diet | No dietary restrictions Free Diet: This diet contains no restrictions. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Free Diet | No dietary restrictions Free Diet: This diet contains no restrictions. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sustained Relapse-free Remission | Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin | 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. | Posted | Count of Participants | Participants | At 52 weeks following enrollment |
|
52 weeks
Adverse event information was obtained via chart review and trial visits
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Free Diet | No dietary restrictions Free Diet: This diet contains no restrictions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronen Stein, MD | The Children's Hospital of Philadelphia | 215-590-7801 | ibdresearch@email.chop.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 10, 2019 | May 8, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Free Diet | Other | This diet contains no restrictions. |
|
|
Change in the microbial composition of the stool, mouth and rectum from baseline to 6 weeks
| 6 weeks |
| 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 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Time-to-relapse | Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin | Not Posted | Up to 104 weeks | 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 | Not Posted | 6 weeks | 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 52 weeks | Not Posted | 52 weeks | Participants |
| Other Pre-specified | Dietary Compliance | Using modified Medication Adherence Rating Scale (MARS) questionnaire | Not Posted | Up to 52 weeks | Participants |
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D007410 | Intestinal Diseases |