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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03058679
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Pennsylvania
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

James D Lewis, MD, MSCE
Principal Investigator Affiliation University of Pennsylvania
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOtherOther
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Wisconsin-Madison, Madison, Wisconsin

Status

Recruiting

Address

University of Wisconsin-Madison

Madison, Wisconsin, 53706

Site Contact

Lindsay Luedke

leluedke@medicine.wisc.edu

608-262-5404

Virginia Mason Medical Center, Seattle, Washington

Status

Recruiting

Address

Virginia Mason Medical Center

Seattle, Washington, 98101

Site Contact

Angie Neal

Angie.Neal@virginiamason.org

206-341-1413

University of Utah, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah

Salt Lake City, Utah, 84112

Site Contact

Julie Will

Julie.will@hsc.utah.edu

801-587-9060

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

Site Contact

Erin Laundry

erin.vozar@Vanderbilt.edu

615-322-4573

Lifespan Health System, Providence, Rhode Island

Status

Recruiting

Address

Lifespan Health System

Providence, Rhode Island, 02903

Site Contact

Patrizia Curran

pcurran1@Lifespan.org

401-793-7824

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

Site Contact

Kimberly Goldby-Reffner, RN

mailto:goldbyreffnerka@upmc.edu

412-648-9173

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Site Contact

Maria Escobar

escobarm@pennmedicine.upenn.edu

215-746-4218

Columbus, Ohio

Status

Recruiting

Address

Ohio State University - Wexner Medical Center

Columbus, Ohio, 43210

Site Contact

Ashley Hatcher

ashley.hatcher@osumc.edu

614-293-2566

Cleveland, Ohio

Status

Recruiting

Address

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

Site Contact

Lynn Richardson

Lynn.Richardson@UHhospitals.org

216-844-7214

University of Cincinnati, Cincinnati, Ohio

Status

Recruiting

Address

University of Cincinnati

Cincinnati, Ohio, 45267

Site Contact

Missy Randolph

RANDOLLJ@ucmail.uc.edu

513-558-5529

Wake Forest Baptist Medical Center, Winston-Salem, North Carolina

Status

Recruiting

Address

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157

Site Contact

Alisha Davis

atdavis@wakehealth.edu

336-713-7319

Charlotte, North Carolina

Status

Recruiting

Address

Atrium Health (formerly Carolinas HealthCare System)

Charlotte, North Carolina, 28203

Site Contact

Jodi Macko, RN

Jodi.Macko@atriumhealth.org

704-355-0282

The University of North Carolina, Chapel Hill, North Carolina

Status

Recruiting

Address

The University of North Carolina

Chapel Hill, North Carolina, 27599

Site Contact

Susan Jackson, MPA

susan_jackson@med.unc.edu

919-843-9071

Lenox Hill Hospital, New York, New York

Status

Recruiting

Address

Lenox Hill Hospital

New York, New York, 10075

Site Contact

Laura Durbin, MPH

ldurbin@northwell.edu

212-434-3941

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Recruiting

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Site Contact

Amy Nolan

amy.nolan@mssm.edu

212-824-7699

Weill Cornell - NewYork Presbyterian, New York, New York

Status

Recruiting

Address

Weill Cornell - NewYork Presbyterian

New York, New York, 10021

Site Contact

Fatiha Chabouni

fac2005@med.cornell.edu

212-746-5109

NYU Langone Medical Center, New York, New York

Status

Recruiting

Address

NYU Langone Medical Center

New York, New York, 10016

Site Contact

Christopher Hawryluk

Christopher.Hawryluk@nyulangone.org

646-501-7984

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire

Status

Recruiting

Address

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756

Site Contact

Penny Doughty

Penny.J.Doughty@hitchcock.org

603-653-6048

Mayo Clinic - Rochester, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic - Rochester

Rochester, Minnesota, 55905

Site Contact

Brenda Becker

becker.brenda1@mayo.edu

507-284-5486

Minnesota Gastroenterology, P.A, Plymouth, Minnesota

Status

Recruiting

Address

Minnesota Gastroenterology, P.A

Plymouth, Minnesota, 55446

Site Contact

Zachary Gleiter

Zachary.Gleiter@mngastro.com

612-870-5594

The University of Minnesota, Minneapolis, Minnesota

Status

Recruiting

Address

The University of Minnesota

Minneapolis, Minnesota, 55455

Site Contact

Levi Teigen, PhD, RD

teige027@umn.edu

215-746-4218

Troy Gastroenterology, Troy, Michigan

Status

Completed

Address

Troy Gastroenterology

Troy, Michigan, 48092

Clinical Research Institute of Michigan, Chesterfield, Michigan

Status

Recruiting

Address

Clinical Research Institute of Michigan

Chesterfield, Michigan, 48047

Site Contact

Aaron Ryder

aryder@researchmi.com

586-598-3329

Boston Children's Hospital, Boston, Massachusetts

Status

Recruiting

Address

Boston Children's Hospital

Boston, Massachusetts, 02115

University of Maryland Baltimore, Baltimore, Maryland

Status

Recruiting

Address

University of Maryland Baltimore

Baltimore, Maryland, 21201

Site Contact

Thelma Harrington

THarrington@som.umaryland.edu

410-706-5943

The University of Louisville, Louisville, Kentucky

Status

Recruiting

Address

The University of Louisville

Louisville, Kentucky, 40202

Site Contact

Suzanne Mann, LPN

mailto:susie.mann@louisville.edu

502-852-1919

Indianapolis, Indiana

Status

Recruiting

Address

Indiana University Health University Hospital

Indianapolis, Indiana, 46202

Site Contact

Debbie Drenzyk

robinsd@iu.edu

317-948-9212

Northwestern University, Evanston, Illinois

Status

Recruiting

Address

Northwestern University

Evanston, Illinois, 60208

Site Contact

Lisa Kim

lisa.kim@northwestern.edu

312-926-5250

NorthShore University HealthSystem, Evanston, Illinois

Status

Recruiting

Address

NorthShore University HealthSystem

Evanston, Illinois, 60201

Site Contact

Obaid Ansari

OAnsari@northshore.org

847-570-3708

University of Chicago, Chicago, Illinois

Status

Recruiting

Address

University of Chicago

Chicago, Illinois, 60614

Site Contact

Talonda Franklin

tfrankli@medicine.bsd.uchicago.edu

773-702-5588

Atlanta Gastroenterology, Atlanta, Georgia

Status

Recruiting

Address

Atlanta Gastroenterology

Atlanta, Georgia, 30342

Emory University, Atlanta, Georgia

Status

Recruiting

Address

Emory University

Atlanta, Georgia, 30322

Site Contact

David Alfa

david.akoji.alfa@emory.edu

404-727-3534

University of Colorado Denver, Denver, Colorado

Status

Recruiting

Address

University of Colorado Denver

Denver, Colorado, 80204

Site Contact

Sandra Boimbo

SANDRA.BOIMBO@UCDENVER.EDU

303-724-8892

UCSF Colitis and Crohn's Disease Center, San Francisco, California

Status

Recruiting

Address

UCSF Colitis and Crohn's Disease Center

San Francisco, California, 94115

Site Contact

Michael Berman

Michael.Berman@ucsf.edu

415-514-8947

University of Arizona, Tucson, Arizona

Status

Recruiting

Address

University of Arizona

Tucson, Arizona, 85724

Site Contact

Ali McInnis, MPH

mailto:amcinnis@email.arizona.edu

520-626-9235

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