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Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease (DINE-CD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03058679
Recruitment Status : Active, not recruiting
First Posted : February 23, 2017
Last Update Posted : October 31, 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)
Actual 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 : March 2020
Estimated Study Completion Date : July 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



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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


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Locations
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United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724
United States, California
UCSF Colitis and Crohn's Disease Center
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado Denver
Denver, Colorado, United States, 80204
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Atlanta Gastroenterology
Atlanta, Georgia, United States, 30342
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60614
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Northwestern University
Evanston, Illinois, United States, 60208
United States, Indiana
Indiana University Health University Hospital
Indianapolis, Indiana, United States, 46202
United States, Kentucky
The University of Louisville
Louisville, Kentucky, United States, 40202
United States, Maryland
University of Maryland Baltimore
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
Clinical Research Institute of Michigan
Chesterfield, Michigan, United States, 48047
Troy Gastroenterology
Troy, Michigan, United States, 48092
United States, Minnesota
The University of Minnesota
Minneapolis, Minnesota, United States, 55455
Minnesota Gastroenterology, P.A
Plymouth, Minnesota, United States, 55446
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
Weill Cornell - NewYork Presbyterian
New York, New York, United States, 10021
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Lenox Hill Hospital
New York, New York, United States, 10075
United States, North Carolina
The University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Atrium Health (formerly Carolinas HealthCare System)
Charlotte, North Carolina, United States, 28203
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Ohio State University - Wexner Medical Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Lifespan Health System
Providence, Rhode Island, United States, 02903
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53706
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: October 31, 2019
Last Verified: October 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