Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease
This protocol is designed to compare the effectiveness of two dietary interventions for patients with Crohn's disease (CD): the Specific Carbohydrate Diet (SCD) and a Mediterranean style diet (MSD) that has been demonstrated to have numerous other health benefits. The two diets will be compared in terms of their ability to resolve both the symptoms and bowel inflammation that characterize this debilitating disease.
- Crohn Disease
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Age ≥18
- Documented diagnosis of Crohn's disease
- sCDAI score >175
- Active inflammation documented by a FCP concentration >250ug/g or high sensitivity C-reactive protein (hs-CRP)>5 mg/L measured at screening.
- Access to a computer with internet and the ability to complete daily online surveys
- Capable of providing consent to participate
- Able to receive weekly food shipments delivered every Friday for 6 weeks
- sCDAI >400
- Hospitalized patients
- Anticipated need for surgery within 6 weeks of randomization
- Use of the Specific Carbohydrate Diet within 4 weeks of screening
- Start or change dose of thiopurines (azathioprine and 6-MP), methotrexate, natalizumab, or vedolizumab within 12 weeks prior to randomization
- Start or change dose of anti-TNF agents (including infliximab, adalimumab, certolizumab pegol, golimumab) or ustekinumab within 8 weeks prior to randomization
- Start or change dose of corticosteroids within 1 week of screening or a dose >20mg/day prednisone or equivalent*
- Known symptomatic intestinal stricture.
- Presence of an ostomy
- Baseline stool frequency >4 bowel movements/day when well
- BMI <16
- BMI ≥40
- Celiac disease
- Documented C difficile colitis within four weeks of screening
- Diabetes Mellitus requiring medication
- Albumin<2.0mg/dl, within 4 weeks of screening (if tested as part of routine clinical care)
- Known allergy to nuts
- Other conditions that would be a contraindication to any of the study diets or preclude the participant from completing the study.
- Currently participating in another clinical trial of a drug to treat IBD or a dietary therapy for any indication.
- Patients may continue these medications at stable dose for the first six weeks and budesonide may be used at any dose. After the 6th week in the study, patients may taper their steroid dose. The study will provide a recommended taper schedule.
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- None (Open Label)
Specific Carbohydrate Diet
Mediterranean Style Diet
- NCT ID
- University of Pennsylvania
Study ContactAdam M Hawkins