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

NCT ID: NCT03058679

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-29
• Study Completion Date: 2020-03-01

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.

Detailed Description

This study tested whether the SCD is superior to a MSD for managing symptoms and reducing inflammatory markers in patients with CD.

The study was designed to include 194 patients with CD who have 1) active symptoms defined by a short Crohn's Disease Activity Index (sCDAI) score >175. Although the initial plan was to also require that all patients have active inflammation documented by a fecal calprotectin (FCP) concentration >250mcg/g or high sensitivity C-reactive protein (CRP) >7 mg/L or ulceration of the small bowel and/or colon consistent with an SES-CD score >4 as documented in routine clinical practice within 4 weeks of screening, a decision was made early in the recruitment period to enroll all patients with CD with sCDAI>175 regardless of the results of the tests for inflammatory markers and to perform subgroup analyses of those with and without evidence of inflammation.

Eligible participants were randomly assigned to follow one of the diets in a 1:1 ratio. Participants were provided with 3 meals and 2 snacks each day for a period of 6 weeks. The meals and snacks were prepared by the food vendor, Healthy Chef Creations, and were delivered directly to the participant's home once per week. Participants in both groups were also provided with instructions on how to follow the diets on their own. Participants reported their symptoms through an electronic diary and provided stool samples for FCP measurement and blood for CRP measurement at weeks 0, 6 and 12. The primary and secondary outcomes were assessed at week 6. Following week 6, participants were able to pay out of pocket to purchase food from Healthy Chef Creations and/or could attempt to follow their assigned diet completely on their own. At week 12, in addition to the primary and secondary outcomes assessed again

Conditions

Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Specific Carbohydrate Diet

For the first six 6 weeks of the trial, participants received a weekly delivery of prepared meals compliant with the SCD (breakfast, lunch, dinner, and two 2 snacks per day). Meals were prepared by Healthy Chef Creations (Orlando, FL) based on menus developed by the food vendor in consultation with study dietitians. Participants assigned to the SCD received a three3-day starter diet as recommended in Breaking the Vicious Cycle. Meals were designed to be heated in an oven or microwave. No other preparation was required.

Group Type: EXPERIMENTAL

Diet

Intervention Type: OTHER

food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks

Mediterranean Style Diet

For the first six 6 weeks of the trial, participants received a weekly delivery of prepared meals compliant with the MD (breakfast, lunch, dinner, and two 2 snacks per day). Meals were prepared by Healthy Chef Creations (Orlando, FL) based on menus developed by the food vendor in consultation with study dietitians. Meals were designed to be heated in an oven or microwave. No other preparation was required.

Group Type: ACTIVE_COMPARATOR

Diet

Intervention Type: OTHER

food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks

Interventions

Diet

food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks

Intervention Type: OTHER

Eligibility 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-tumor necrosis factor (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-aminosalicylic acid (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 Inflammatory Bowel Disease (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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Crohn's and Colitis Foundation

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James D Lewis, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Arizona

Tucson, Arizona, United States

UCSF Colitis and Crohn's Disease Center

San Francisco, California, United States

University of Colorado Denver

Denver, Colorado, United States

Emory University

Atlanta, Georgia, United States

Atlanta Gastroenterology

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

NorthShore University HealthSystem

Evanston, Illinois, United States

Northwestern University

Evanston, Illinois, United States

Indiana University Health University Hospital

Indianapolis, Indiana, United States

The University of Louisville

Louisville, Kentucky, United States

University of Maryland Baltimore

Baltimore, Maryland, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Clinical Research Institute of Michigan

Chesterfield, Michigan, United States

Troy Gastroenterology

Troy, Michigan, United States

The University of Minnesota

Minneapolis, Minnesota, United States

Minnesota Gastroenterology, P.A

Plymouth, Minnesota, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

NYU Langone Medical Center

New York, New York, United States

Weill Cornell - NewYork Presbyterian

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Lenox Hill Hospital

New York, New York, United States

The University of North Carolina

Chapel Hill, North Carolina, United States

Atrium Health (formerly Carolinas HealthCare System)

Charlotte, North Carolina, United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Ohio State University - Wexner Medical Center

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Lifespan Health System

Providence, Rhode Island, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Utah

Salt Lake City, Utah, United States

Virginia Mason Medical Center

Seattle, Washington, United States

University of Wisconsin-Madison

Madison, Wisconsin, United States

Countries

United States

References

Lewis JD, Sandler RS, Brotherton C, Brensinger C, Li H, Kappelman MD, Daniel SG, Bittinger K, Albenberg L, Valentine JF, Hanson JS, Suskind DL, Meyer A, Compher CW, Bewtra M, Saxena A, Dobes A, Cohen BL, Flynn AD, Fischer M, Saha S, Swaminath A, Yacyshyn B, Scherl E, Horst S, Curtis JR, Braly K, Nessel L, McCauley M, McKeever L, Herfarth H; DINE-CD Study Group. A Randomized Trial Comparing the Specific Carbohydrate Diet to a Mediterranean Diet in Adults With Crohn's Disease. Gastroenterology. 2021 Sep;161(3):837-852.e9. doi: 10.1053/j.gastro.2021.05.047. Epub 2021 May 27.

Reference Type: DERIVED

PMID: 34052278 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

825907

Identifier Type: -

Identifier Source: org_study_id