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Trial record 1 of 1 for:    03058679
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Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease (DINE-CD)

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ClinicalTrials.gov Identifier: NCT03058679
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : May 9, 2019
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
Crohn's and Colitis Foundation
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
University of Pennsylvania

Brief 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.

Condition or disease Intervention/treatment Phase
Crohn Disease Other: Diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label, Randomized, Multicenter, Comparative Effectiveness Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients With Crohn's Disease
Actual Study Start Date : September 29, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Symptomatic remission [ Time Frame: 6 weeks ]
    Assessed by Short Crohn's Disease Activity Index (sCDAI) - diarrhea, abdominal pain and general well being

  2. Reduction in bowel inflammation [ Time Frame: 6 weeks ]
    Calprotectin <250 mcg/gm and >50% reduction from baseline


Secondary Outcome Measures :
  1. Clinical remission [ Time Frame: 6 weeks ]
    Assessed by the Harvey Bradshaw Index

  2. Reduction in systemic inflammation [ Time Frame: 6 weeks ]
    hsCRP < 5mg/L >50% reduction from baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  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

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 (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.

    • 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.

      • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03058679


Contacts
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Contact: Maria Escobar 215-746-4218 escobarm@pennmedicine.upenn.edu
Contact: Lisa C Nessel, MSS, MLSP 215-573-6003 nessel@pennmedicine.upenn.edu

  Show 35 Study Locations
Sponsors and Collaborators
University of Pennsylvania
Patient-Centered Outcomes Research Institute
Crohn's and Colitis Foundation
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: James D Lewis, MD, MSCE University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03058679     History of Changes
Other Study ID Numbers: 825907
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Pennsylvania:
diet
specific carbohydrate diet
Mediterranean style diet
randomized controlled trial
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases