Crohn's Disease Clinical Trial
Official title:
Specific Carbohydrate Diet as Maintenance Therapy in Crohn's Disease
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:
1. History of symptoms
2. Physical exam including height, weight, BMI, Tanner staging
3. Calculation of Pediatric Crohn's Disease Activity Index (PCDAI) for pediatric patients
or the Crohn's Disease Activity Index (CDAI) score for adult patients.
4. Dietary assessment and nutritional counseling
5. Completion of validated quality of life measurement (IMPACT III for pediatric patients
and SIBDQ in adult patients)
6. Adverse event monitoring (record of symptoms and review of laboratory surveillance)
7. Laboratory assessment including: CBC with differential, basic metabolic panel, liver
function tests, albumin, ESR, CRP, stool calprotectin and stool lactoferrin
8. Serum sample for cytokine studies
9. Stool studies for microbiota studies
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