Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Age ≥18
  2. Documented diagnosis of Crohn's disease
  3. sCDAI score >175
  4. Access to a computer with internet and the ability to complete daily online surveys
  5. Capable of providing consent to participate
  6. Able to receive weekly food shipments delivered every Friday for 6 weeks

Exclusion Criteria

  1. Pregnancy
  2. sCDAI >400
  3. Hospitalized patients
  4. Anticipated need for surgery within 6 weeks of randomization
  5. Use of the Specific Carbohydrate Diet within 4 weeks of screening
  6. Start or change dose of thiopurines (azathioprine and 6-MP), methotrexate, natalizumab, or vedolizumab within 12 weeks prior to screening
  7. Start or change dose of anti-TNF agents (including infliximab, adalimumab, certolizumab pegol, golimumab) or ustekinumab within 8 weeks prior to screening
  8. Start or change dose of corticosteroids within 1 week of screening or a dose >20mg/day prednisone or equivalent*
  9. Use of antibiotics within 2 weeks of screening.
  10. Known symptomatic intestinal stricture.
  11. Presence of an ostomy
  12. Baseline stool frequency >4 bowel movements/day when well
  13. BMI <16
  14. BMI ≥40
  15. Celiac disease
  16. Documented C difficile colitis within four weeks of screening
  17. Diabetes Mellitus requiring medication
  18. Albumin<2.0mg/dl, within 4 weeks of screening (if tested as part of routine clinical care)
  19. Known allergy to nuts
  20. Other conditions that would be a contraindication to any of the study diets or preclude the participant from completing the study.
  21. Currently participating in another clinical trial of a drug to treat IBD or a dietary therapy for any indication.
  22. 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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Specific Carbohydrate Diet
  • Other: Diet
    food for the diet will be provided to the participants for 6 weeks
Active Comparator
Mediterranean Style Diet
  • Other: Diet
    food for the diet will be provided to the participants for 6 weeks

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Erin Laundry
615-322-4573
erin.vozar@Vanderbilt.edu

More Details

NCT ID
NCT03058679
Status
Recruiting
Sponsor
University of Pennsylvania

Study Contact

Adam M Hawkins
215-746-4218
ahawkeye@pennmedicine.upenn.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.