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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

Open Label, Randomized, Multicenter, Comparative Effectiveness Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients With Crohn's Disease

Keywords

Crohn Disease diet specific carbohydrate diet Mediterranean style diet randomized controlled trial

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Age ≥18
  2. Documented diagnosis of Crohn's disease
  3. sCDAI score >175
  4. Active inflammation documented by a FCP concentration >250ug/g (or >300 ug/g measured via Point-of-Care FCP testing) or high sensitivity C-reactive protein (hs-CRP)>5 mg/L measured at screening.
  5. Access to a computer with internet and the ability to complete daily online surveys
  6. Capable of providing consent to participate
  7. Able to receive weekly food shipments delivered every Friday for 6 weeks

You CAN'T join if...

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

Locations

  • UCSF Colitis and Crohn's Disease Center accepting new patients
    San Francisco, California, 94115, United States
  • Virginia Mason Medical Center accepting new patients
    Seattle, Washington, 98101, United States
  • Minnesota Gastroenterology, P.A accepting new patients
    Plymouth, Minnesota, 55446, United States
  • Indiana University Health University Hospital accepting new patients
    Indianapolis, Indiana, 46202, United States
  • University of Cincinnati accepting new patients
    Cincinnati, Ohio, 45267, United States
  • University of Michigan accepting new patients
    Ann Arbor, Michigan, 48109, United States
  • Clinical Research Institute of Michigan accepting new patients
    Chesterfield, Michigan, 48047, United States
  • University Hospitals Cleveland Medical Center accepting new patients
    Cleveland, Ohio, 44106, United States
  • The University of North Carolina accepting new patients
    Chapel Hill, North Carolina, 27599, United States
  • University of Maryland Baltimore accepting new patients
    Baltimore, Maryland, 21201, United States
  • University of Pennsylvania accepting new patients
    Philadelphia, Pennsylvania, 19104, United States
  • NYU Langone Medical Center accepting new patients
    New York, New York, 10016, United States
  • Icahn School of Medicine at Mount Sinai accepting new patients
    New York, New York, 10029, United States
  • Dartmouth-Hitchcock Medical Center accepting new patients
    Lebanon, New Hampshire, 03756, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Pennsylvania
ID
NCT03058679
Lead Scientist
Uma Mahadevan
Study Type
Interventional
Last Updated
December 21, 2017
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