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



Status:Recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:September 29, 2017
End Date:January 2020
Contact:Adam M Hawkins
Email:ahawkeye@pennmedicine.upenn.edu
Phone:215-746-4218

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Open Label, Randomized, Multicenter, Comparative Effectiveness Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients With Crohn's Disease

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.


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.
We found this trial at
36
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Bridget Hron, MD
Phone: 617-919-4592
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201 Dowman Dr
Atlanta, Georgia 30303
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Principal Investigator: Heba Iskandar, MD
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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621 West Lombard Street
Baltimore, Maryland 21201
(410) 706-7101
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: David Rubin, MD
Phone: 773-702-5588
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Eugenia Shmidt, MD
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Sara Horst, MD
Phone: 615-322-4573
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Ann Flynn, MD
Phone: 801-587-9060
University of Utah Research is a major component in the life of the U benefiting...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Peter D Higgins, MD
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Atlanta, Georgia 30308
Principal Investigator: Douglas Wolf, MD
Phone: 404-257-9000
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Hans Herfarth, MD, PhD
Phone: 919-843-9071
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Chesterfield, Michigan 48098
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2600 Clifton Ave
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(513) 556-6000
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Cleveland, Ohio 44012
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
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Denver, Colorado 80291
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Evanston, Illinois
Principal Investigator: Eugene Yen,, MD
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Evanston, Illinois 60208
Principal Investigator: Stephen B Hanauer, MD
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Indianapolis, Indiana 46202
Principal Investigator: Monika Fischer, MD
Phone: 317-948-9212
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: L. Campbell Levy, MD
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Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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500 S Preston St
Louisville, Kentucky
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Principal Investigator: Gerald W Dryden, MD
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Madison, Wisconsin 53706
(608) 263-2400
Principal Investigator: Sumona Saha, MD
Phone: 608-262-5404
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New York, New York 10016
Principal Investigator: David Hudesman, MD
Phone: 646-501-7984
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: Benjamin Cohen, MD
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New York, New York 10021
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New York, New York 10021
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
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Winston-Salem, North Carolina 27157
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