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. Documentation of receipt of a baseline stool sample by the data coordinating center and hsCRP.
  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 screening
  7. Start or change*** dose of anti-TNF agents (including infliximab (Remicade), adalimumab (Humira), certolizumab pegol (Cimzia), golimumab (Simponi) or ustekinumab within 8 weeks prior to screening.
  8. Start or change in dose of any 5-ASA medications within 2 weeks of screening.
  9. Start or change dose of corticosteroids within 1 week of screening or a dose >20mg/day prednisone or equivalent*
  10. . Use of antibiotics (other than topical formulations) for any reason within 2 weeks prior to screening
  11. . Known symptomatic intestinal stricture.
  12. . Presence of an ostomy
  13. . Baseline stool frequency >4 bowel movements/day when well
  14. . BMI <16
  15. . BMI ≥40
  16. . Celiac disease
  17. . Documented C difficile colitis within four weeks of screening
  18. . Diabetes Mellitus requiring medication
  19. . Albumin<2.0mg/dl, within 4 weeks of screening (if tested as part of routine clinical care)
  20. . Known allergy to tree nuts or peanuts
  21. . Other conditions that would be a contraindication to any of the study diets or preclude the participant from completing the study.
  22. . Currently participating in another clinical trial of a drug to treat IBD or a dietary therapy for any indication.
  23. 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.
  24. Loading/induction doses of biologic type medication will be considered a stable doses. ***Exception for treatment failures: if a subject is determined to fail on any of the following standard lines of treatment at the treating investigator's discretion, subjects may screen for study intervention based upon the following wash out periods: 4 weeks for thiopurine and methotrexate and 8 weeks for natalizumab, vedolizumab, anti-TNF, or ustekinumab.

Locations

  • UCSF Colitis and Crohn's Disease Center
    San Francisco California 94115 United States
  • University of Utah
    Salt Lake City Utah 84112 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Pennsylvania
ID
NCT03058679
Study Type
Interventional
Last Updated