Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-010217
    NCT ID: NCT03058679
    Sponsor Protocol Number: 825907

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  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 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

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 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.
    • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sunanda Kane, M.D.

Open for enrollment

Contact information:

Brenda Becker CCRP

(507)266-0111

Becker.Brenda1@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20395686

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