Specific Carbohydrate Diet as Maintenance Therapy in Crohn's Disease (SCD)

• Specific Carbohydrate Diet as Maintenance Therapy in Crohn's Disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  The primary end point of the study is the proportion of patients achieving steroid free remission at 1 year
  
  

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).

Standard 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 thiopurine metabolites (if indicated at the 2 month visit)
8. Serum sample for lymphocyte and cytokine studies (Nadeau lab)
9. Stool studies for microbiota studies (Relman lab)

At enrollment, additional laboratory value includes:

1. Quantiferon TB test or PPD placement
2. Varicella IgG (if no known history of varicella)
3. IBD-7 serology
4. TPMT enzyme (for individualized starting dose of thiopurines)
5. Stool culture and Clostridium difficile toxin PCR

All patients will receive initial therapy, known as induction therapy, with corticosteroids 1-2mg/kg/day (up to 60mg maximum) for 2 weeks. At 2 weeks, the patients will be evaluated for improved symptoms and/or a decline in PCDAI of 12.5 points (pediatric patients) or decline in CDAI of 70 points (adult patients).

Patients responsive to steroids at 2 weeks (as defined above) will choose to follow either the SCD or start an immunomodulator medication (including mercaptopurine, azathioprine or methotrexate after discussion with their physician). Medication doses are based on weight and for thiopurines specifically by enzyme activity level. Patients will not be randomized to the treatment arms. For both treatment arms, once patients reach remission (defined as PCDAI <10 or CDAI <150) they will begin a standard steroid taper over the next 8-12weeks. Patients that do not reach remission by 4 weeks will be excluded from the study.

As is standard of care for patients with Crohn's disease, recommendations will be made for keeping vaccinations up to date including yearly influenza vaccine, ophthalmologic examination and a DEXA scan (if patients require greater than 3 months of chronic steroid therapy) during the next year of followup.

Patients will be seen in clinic at diagnosis, 2 weeks, 1 month, 2 months, 3 months and then every 3 months until a flare of symptoms or one year, whichever comes first. Worsening of symptoms, known as disease flare, is defined as PCDAI score >30 points or CDAI >220 points. The primary endpoint is the proportion of patients in steroid free remission at 1 year, defined as PCDAI <10 points and CDAI <150 points.