Specific Carbohydrate Diet as Maintenance Therapy in 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:

• History of symptoms
• Physical exam including height, weight, BMI, Tanner staging
• Calculation of Pediatric Crohn's Disease Activity Index (PCDAI) for pediatric patients or the Crohn's Disease Activity Index (CDAI) score for adult patients.
• Dietary assessment and nutritional counseling
• Completion of validated quality of life measurement (IMPACT III for pediatric patients and SIBDQ in adult patients)
• Adverse event monitoring (record of symptoms and review of laboratory surveillance)
• Laboratory assessment including: CBC with differential, basic metabolic panel, liver function tests, albumin, ESR, CRP, stool calprotectin and stool lactoferrin
• Serum sample for cytokine studies
• Stool studies for microbiota studies

Inclusion criteria

• Adult or pediatric patients presenting with a new diagnosis or flare of existing Crohn's disease based on standard diagnostic criteria including: clinical symptoms, laboratory parameters, disease activity indices (Pediatric Crohn's Disease Activity Index (PCDAI) for patients <19years and Crohn's Disease Activity Index (CDAI) for patients >19years), pathology from upper endoscopy/colonoscopy and imaging studies.

Exclusion criteria

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• Pregnancy
• Other autoimmune conditions including celiac disease, rheumatoid arthritis, multiple sclerosis
• Otherwise immunosuppressed patients including HIV and prior organ transplant
• Patients diagnosed with ulcerative colitis or indeterminate colitis
• Active tuberculosis