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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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Locations
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United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
Contact: Ali McInnis, MPH    520-626-9235    mailto:amcinnis@email.arizona.edu   
Principal Investigator: Sasha Taleban, MD         
United States, California
UCSF Colitis and Crohn's Disease Center Recruiting
San Francisco, California, United States, 94115
Contact: Michael Berman    415-514-8947    Michael.Berman@ucsf.edu   
Principal Investigator: Uma Mahadevan, MD         
United States, Colorado
University of Colorado Denver Recruiting
Denver, Colorado, United States, 80204
Contact: Sandra Boimbo    303-724-8892    SANDRA.BOIMBO@UCDENVER.EDU   
Principal Investigator: Mark Gerich, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: David Alfa    404-727-3534    david.akoji.alfa@emory.edu   
Principal Investigator: Heba Iskandar, MD         
Atlanta Gastroenterology Recruiting
Atlanta, Georgia, United States, 30342
Contact: Christine Wolf    404-257-9000 ext 2142    mailto:christine.wolf@atlantagastro.com   
Principal Investigator: Douglas Wolf, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60614
Contact: Talonda Franklin    773-702-5588    tfrankli@medicine.bsd.uchicago.edu   
Principal Investigator: David Rubin, MD         
NorthShore University HealthSystem Recruiting
Evanston, Illinois, United States, 60201
Contact: Obaid Ansari    847-570-3708    OAnsari@northshore.org   
Principal Investigator: Eugene Yen,, MD         
Northwestern University Recruiting
Evanston, Illinois, United States, 60208
Contact: Lisa Kim    312-926-5250    lisa.kim@northwestern.edu   
Principal Investigator: Stephen B Hanauer, MD         
United States, Indiana
Indiana University Health University Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Debbie Drenzyk    317-948-9212    robinsd@iu.edu   
Principal Investigator: Monika Fischer, MD         
United States, Kentucky
The University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Suzanne Mann, LPN    502-852-1919    mailto:susie.mann@louisville.edu   
Principal Investigator: Gerald W Dryden, MD         
United States, Maryland
University of Maryland Baltimore Recruiting
Baltimore, Maryland, United States, 21201
Contact: Thelma Harrington    410-706-5943    THarrington@som.umaryland.edu   
Sub-Investigator: Sandra Quezada, MD         
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Caroline Rourke    617-919-4592    Caroline.Rourke@childrens.harvard.edu   
Principal Investigator: Bridget Hron, MD         
United States, Michigan
Clinical Research Institute of Michigan Recruiting
Chesterfield, Michigan, United States, 48047
Contact: Aaron Ryder    586-598-3329    aryder@researchmi.com   
Principal Investigator: Ronald P Fogel, MD         
Troy Gastroenterology Completed
Troy, Michigan, United States, 48092
United States, Minnesota
The University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Levi Teigen, PhD, RD       teige027@umn.edu   
Principal Investigator: Eugenia Shmidt, MD         
Minnesota Gastroenterology, P.A Recruiting
Plymouth, Minnesota, United States, 55446
Contact: Zachary Gleiter    612-870-5594    Zachary.Gleiter@mngastro.com   
Principal Investigator: Robert McCabe, MD         
Mayo Clinic - Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Brenda Becker    507-284-5486    becker.brenda1@mayo.edu   
Principal Investigator: Sunanda Kane, MD         
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Penny Doughty    603-653-6048    Penny.J.Doughty@hitchcock.org   
Principal Investigator: L. Campbell Levy, MD         
United States, New York
NYU Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Christopher Hawryluk    646-501-7984    Christopher.Hawryluk@nyulangone.org   
Principal Investigator: David Hudesman, MD         
Weill Cornell - NewYork Presbyterian Recruiting
New York, New York, United States, 10021
Contact: Fatiha Chabouni    212-746-5109    fac2005@med.cornell.edu   
Principal Investigator: Ellen J Scherl, MD         
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Amy Nolan    212-824-7699    amy.nolan@mssm.edu   
Contact: Sari Feldman    212-824-7669    sari.feldman@mssm.edu   
Principal Investigator: Benjamin Cohen, MD         
Lenox Hill Hospital Recruiting
New York, New York, United States, 10075
Contact: Laura Durbin, MPH    212-434-3941    ldurbin@northwell.edu   
Principal Investigator: Arun Swaminath, MD         
United States, North Carolina
The University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Susan Jackson, MPA    919-843-9071    susan_jackson@med.unc.edu   
Principal Investigator: Hans Herfarth, MD, PhD         
Atrium Health (formerly Carolinas HealthCare System) Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Jodi Macko, RN    704-355-0282    Jodi.Macko@atriumhealth.org   
Principal Investigator: John Hanson, MD         
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Alisha Davis    336-713-7319    atdavis@wakehealth.edu   
Principal Investigator: Patrick Green, MD         
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Missy Randolph    513-558-5529    RANDOLLJ@ucmail.uc.edu   
Principal Investigator: Bruce Yacyshyn, MD         
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Lynn Richardson    216-844-7214    Lynn.Richardson@UHhospitals.org   
Principal Investigator: Jeffry Katz, MD         
Ohio State University - Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Ashley Hatcher    614-293-2566    ashley.hatcher@osumc.edu   
Principal Investigator: Anita Afzali, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Maria Escobar    215-746-4218    escobarm@pennmedicine.upenn.edu   
Principal Investigator: James D Lewis, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kimberly Goldby-Reffner, RN    412-648-9173    mailto:goldbyreffnerka@upmc.edu   
Principal Investigator: Marc Schwartz, MD         
United States, Rhode Island
Lifespan Health System Recruiting
Providence, Rhode Island, United States, 02903
Contact: Patrizia Curran    401-793-7824    pcurran1@Lifespan.org   
Principal Investigator: Colleen Kelly, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Erin Laundry    615-322-4573    erin.vozar@Vanderbilt.edu   
Principal Investigator: Sara Horst, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Julie Will    801-587-9060    Julie.will@hsc.utah.edu   
Principal Investigator: Ann Flynn, MD         
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Angie Neal    206-341-1413    Angie.Neal@virginiamason.org   
Principal Investigator: Michael Chiorean, MD         
United States, Wisconsin
University of Wisconsin-Madison Recruiting
Madison, Wisconsin, United States, 53706
Contact: Lindsay Luedke    608-262-5404    leluedke@medicine.wisc.edu   
Principal Investigator: Sumona Saha, MD         
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