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This study investigates whether the specific carbohydrate diet (SCD) can maintain clinical remission in pediatric and adult patients with Crohn's disease.
Patients will be seen in clinic at new diagnosis of Crohn's disease or a flare of existing disease. Potential subjects will be screened with for eligibility, followed by a baseline assessment by the clinic provider. Subjects who wish to participate will undergo further discussion with one of the study staff. At enrollment, a member of the study staff will explain the study to the prospective participant (for consent and/or assent, if applicable given patient's age).
The SCD will be started in addition to previous maintenance medication therapy or with short course of corticosteroids 1-2mg/kg/day (up to 60mg maximum). Steroid induction based on clinical need.
We anticipate improvement in clinical symptoms, laboratory values and/or a decline in PCDAI of 12.5 points (pediatric patients) or decline in CDAI of 70 points (adult patients) after 4 weeks. Patients who do not reach remission by 4 weeks will be excluded from the study. Patients who require additional medications for disease control will be excluded from the study.
Patients will be seen in clinic at diagnosis, 2 weeks (if required by clinical symptoms), 1 month, 3 months and 6 months.
Assessment at initial enrollment and at all follow-up visits includes:
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| Measure | Description | Time Frame |
|---|---|---|
| Specific Carbohydrate Diet as Maintenance Therapy in Crohn's Disease | The primary end point of the study is the proportion of patients achieving steroid free remission at 6 months | 1 year |
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Inclusion Criteria:
Exclusion Criteria:)
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Children under 18 Adult
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| Name | Affiliation | Role |
|---|---|---|
| Ken Cox, MD | Stanford University Medical | Principal Investigator |
| Shamita Shah, MD | Stanford University Medicial | Principal Investigator |
| Jennifer Burgis, MD | Stanford University Medical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Palo Alto | California | 94304 | United States | ||
| Stanford |
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| Label | URL |
|---|---|
| Specific Carbohydrate Diet in Crohn's Disease | View source |
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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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Blood and stool
| Palo Alto |
| California |
| 94304 |
| United States |
| D007410 | Intestinal Diseases |