General Information:

Title of Study

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

Phase of study

n/a

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Eligibility:

Age

Adult (18+)

Gender

Female, Male

Disease Type

Crohn’s Disease

Severity

Mild, Moderate

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.

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Study Details:

Study Description

The DINE-CD study seeks to compare the efficacy of two different dietary strategies to reduce symptoms and inflammation in Crohn's disease. The two diets being studied are the Mediterranean style diet and the Specific Carbohydrate Diet (SCD). Participants will be assigned to one of the two diets for a 12 week period. During the first six weeks, participants will be provided with all of their food. For the last six weeks, participants will be asked to follow the diet on their own (with the option to purchase some or all of their meals from the same vendor providing food during the first six weeks). During the duration of the study, participants will complete three study visits at one of the study sites located throughout the United States.

Description of Treatment or Intervention (Mechanism of Action)

  • A Mediterranean style diet is rich in fiber and plant-based food. It also includes olive oil, low fat dairy, herbs, and spices. Poultry, eggs, cheese, and yogurt are eaten in moderation, and red meat is eaten rarely. Research has shown that a Mediterranean style diet has numerous health benefits, including reducing the risk of heart disease and lowering cholesterol as well as reducing incidence of cancer and Parkinson's and Alzheimer's diseases. 
  • SCD eliminates refined/processed foods and many type of carbohydrates as well as soy, lactose, sucrose, and grains, and certain vegetables such as potatoes, okra and corn. This diet can be low in certain nutrients, such as B vitamins, calcium, vitamin D, and vitamin E.

Patient Participation Requirements

18 years old or older, mild to moderate Crohn's disease, stable dose of medications prior to screening.

Possible Risks & Side Effects

Your Crohn's Disease may not get better or may get worse while on study. Additionally, with any research study, a breach of confidentiality may occur.

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Contact Information:

Site Locations

University of Pennsylvania421 Guardian DrivePhiladelphia, PA 19130
Adam Hawkins215-746-4218ahawkeye@pennmedicine.upenn.edu
Atlanta Gastroenterology Associates340 Boulevard NE Suite 145 Atlanta, GA 30312
Christine Wolf404-257-9000,2142 christine.wolf@atlantagastro.com
Carolinas HealthCare System Digestive Health1025 Morehead Medical Dr #300, Charlotte, NC 28204
Jodi Mako704-355-0282 Jodi.Macko@carolinashealthcare.org
Clinical Research Institute of Michigan, LLC30795 23 Mile Rd Suite 206 Chesterfield, MI 48047
Brittany McKenzie586-598-3329bmckenzie@researchmi.com
Dartmouth-Hitchcock Medical Center Main Site 1 Medical Center Dr Lebanon, NH 03766
Penny Doughty603-695-2513 Penny.J.Doughty@hitchcock.org
Dartmouth-Hitchcock Medical Center Sub-site1 Medical Center DrLebanon, NH 03766
Chantal Lambert-Harris603-695-2513 Chantal.A.Lambert-Harris@hitchcock.org
Emory University School of MedicineEmory Clinic at 1365 Clifton Rd 1365 Clifton Rd NE Bldg B Atlanta, GA 30322
David Alfa404.727.3534david.akoji.alfa@emory.edu
Icahn School of Medicine at Mount Sinai Hosptial17 East 102nd Street, 5th FloorNew York, NY 10029
Amy Nolan212.824.7699Amy.Nolan@mssm.edu
IU Health University Hospital550 N. University Blvd. Suite 1634 Indianapolis , IN 46202-2859
Debbie E Drenzyk317-948-9212robinsd@iu.edu
Mayo Clinic Rochester1216 2nd St SW Rochester, MN 55902
Brenda D. Becker507-284-5486 becker.brenda1@mayo.edu
Minnesota Gastroenterology, P.A15700 37th Ave NPlymouth, MN 55446
Irena Davies612-870-5587Irena.Davies@mngastro.com
Northshore University Healthsystem1000 Central St. Suite 615 Evanston, IL 60201
Obaid Ansari847 570 3708OAnsari@northshore.org
NorthwesternNMH/Arkes Family Pavilion Suite 1400 676 N Saint Clair Chicago IL 60611
Lisa Kim 312-926-5250lisa.kim@northwestern.edu
Shafran Gastroenterology Center
DINECDStudy@mail.med.upenn.edu
UCSF Colitis and Crohn's Disease Center1701 Divisadero St #120San Francisco, CA 94115
Michael Berman(415) 514-8947Michael.Berman@ucsf.edu
University of Colorado Denver1635 Aurora Ct 5th Floor Aurora, CO 80045
Sandra Boimbo303.724.8892 SANDRA.BOIMBO@UCDENVER.EDU
University of Louisville401 E. Chestnut St. Suite 310 Louisville, KY 40202
Susie Mann(502) 852-1919suzanne.mann@louisville.edu
University of Michigan1500 E Medical Center Dr # 391 Ann Arbor, MI 48109
Kimberly Brunette734-647-4548kbrunett@med.umich.edu
University of North Carolina101 Manning DrChapel Hill, NC 27514
Christian Munoz Pineda(919) 843-7643christian_munozpineda@med.unc.edu
University of Wisconsin600 HIGHLAND AVE Madison, WI 53792
Lindsay Luedke608.262.5404leluedke@medicine.wisc.edu
Vanderbilt Medical Center1301 Medical Center Dr #1660, Nashville, TN 37212
Erin Landry 615.322.4573erin.vozar@Vanderbilt.Edu
Weill Cornell Medicine1315 York Avenue, MezzanineNew York, NY 10021
Fatiha Chabouni(212) 746-5109fac2005@med.cornell.edu
University of Utah30 N 1900 E # 4R11Salt Lake City, UT 84132
Julie Will801-587-9060 julie.will@hsc.utah.edu
University of Cincinnati222 Piedmont AveCincinnati, OH 45219
Loretta (Missy) Randolph513-558-5529RANDOLLJ@ucmail.uc.edu
University of Pittsburgh Medical Center (UPMC)UPMC Presbyterian, Third Floor, 200 Lothrop StPittsburgh, PA 15213
Kimberly Goldby-Reffner412-648-9173goldbyreffnerka@upmc.edu
Wake Forest University1 Medical Center BlvdWinston-Salem, NC 27157
Alisha Takeela Davis336.713.7319 atdavis@wakehealth.edu
University Hospitals Case Medical Center11100 Euclid AveCleveland, OH 44106
Lynn Richardson216-844-7214Lynn.Richardson@UHhospitals.org
University of Maryland School of Medicine22 S Greene StBaltimore, MD 21201
Thelma Harrington410-706-5943 THarrington@som.umaryland.edu
Virginia Mason Medical Center1100 9th AveSeattle, WA 98101
Adrian Parker(206) 341-1710 Adrian.Parker@virginiamason.org
Lenox Hill Hospital178 East 85th Street Suite 4th Floor New York, NY 10028
Laura Durbin212-434-3941ldurbin@northwell.edu
Boston Children's Hospital300 Longwood AveBoston, MA 02115
Caroline Rourke617-919-4592Caroline.Rourke@childrens.harvard.edu
University of Chicago 5841 S Maryland AveChicago, IL 60637
Talonda Franklin773-702-5588tfrankli@medicine.bsd.uchicago.edu
Charlotte Gastroenterology & Hepatology2015 Randolph RdCharlotte, NC 28207
Lori Sell704-375-9485 Lori.Sell@charlottegastro.com
NYU Langone Medical Center240 E 38th StNew York, NY 10016
Gregory Pappas646-501-7984 Gregory.Pappas@nyumc.org

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