Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease
DINE-CD
Open Label, Randomized, Multicenter, Comparative Effectiveness Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients With Crohn's Disease
1 other identifier
interventional
197
1 country
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2017
Typical duration for not_applicable
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedStudy Start
First participant enrolled
September 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedResults Posted
Study results publicly available
July 21, 2021
CompletedJuly 21, 2021
June 1, 2021
2.4 years
February 16, 2017
March 26, 2021
June 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants That Achieved Symptomatic Remission at Week 6
Assessed by Short Crohn's Disease Activity Index (sCDAI) - diarrhea, abdominal pain and general well being; sCDAI \<150 in the absence of initiation or increase of any CD medications
6 weeks
Reduction in Bowel Inflammation Among Those Whose Screening Fecal Calprotectin (FC) Was Greater Than 250μg/g at Baseline and Who Had an FC Results at Both Baseline and Week 6
reduction of calprotectin to less than 250 μg/g and by greater than 50% from screening among those with screening FC \>250 μg/g
6 weeks
Secondary Outcomes (2)
Percentage of Participants That Reached Clinical Remission at Week 6
6 weeks
Percentage of Participants With a Reduction in Systemic Inflammation at Week 6
6 weeks
Study Arms (2)
Specific Carbohydrate Diet
EXPERIMENTALFor 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.
Mediterranean Style Diet
ACTIVE COMPARATORFor 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- Age ≥18
- Documented diagnosis of Crohn's disease
- sCDAI score \>175
- Documentation of receipt of a baseline stool sample by the data coordinating center and hsCRP.
- Access to a computer with internet and the ability to complete daily online surveys
- Capable of providing consent to participate
- Able to receive weekly food shipments delivered every Friday for 6 weeks
You may not qualify if:
- Pregnancy
- sCDAI \>400
- Hospitalized patients
- Anticipated need for surgery within 6 weeks of randomization
- Use of the Specific Carbohydrate Diet within 4 weeks of screening
- Start or change\*\*\* dose of thiopurines (azathioprine and 6-MP), methotrexate, natalizumab, or vedolizumab within 12 weeks prior to screening
- 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.
- Start or change in dose of any 5-aminosalicylic acid (5-ASA) medications within 2 weeks of screening.
- Start or change dose of corticosteroids within 1 week of screening or a dose \>20mg/day prednisone or equivalent\*
- Use of antibiotics (other than topical formulations) for any reason within 2 weeks prior to screening
- Known symptomatic intestinal stricture.
- Presence of an ostomy
- Baseline stool frequency \>4 bowel movements/day when well
- BMI \<16
- BMI ≥40
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- Patient-Centered Outcomes Research Institutecollaborator
- Crohn's and Colitis Foundationcollaborator
- University of North Carolina, Chapel Hillcollaborator
Study Sites (35)
University of Arizona
Tucson, Arizona, 85724, United States
UCSF Colitis and Crohn's Disease Center
San Francisco, California, 94115, United States
University of Colorado Denver
Denver, Colorado, 80204, United States
Emory University
Atlanta, Georgia, 30322, United States
Atlanta Gastroenterology
Atlanta, Georgia, 30342, United States
University of Chicago
Chicago, Illinois, 60614, United States
NorthShore University HealthSystem
Evanston, Illinois, 60201, United States
Northwestern University
Evanston, Illinois, 60208, United States
Indiana University Health University Hospital
Indianapolis, Indiana, 46202, United States
The University of Louisville
Louisville, Kentucky, 40202, United States
University of Maryland Baltimore
Baltimore, Maryland, 21201, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Clinical Research Institute of Michigan
Chesterfield, Michigan, 48047, United States
Troy Gastroenterology
Troy, Michigan, 48092, United States
The University of Minnesota
Minneapolis, Minnesota, 55455, United States
Minnesota Gastroenterology, P.A
Plymouth, Minnesota, 55446, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
NYU Langone Medical Center
New York, New York, 10016, United States
Weill Cornell - NewYork Presbyterian
New York, New York, 10021, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Lenox Hill Hospital
New York, New York, 10075, United States
The University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Atrium Health (formerly Carolinas HealthCare System)
Charlotte, North Carolina, 28203, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Ohio State University - Wexner Medical Center
Columbus, Ohio, 43210, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Lifespan Health System
Providence, Rhode Island, 02903, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
University of Utah
Salt Lake City, Utah, 84112, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
University of Wisconsin-Madison
Madison, Wisconsin, 53706, United States
Related Publications (1)
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.
PMID: 34052278DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. James D. Lewis
- Organization
- University of Pennsylvania
Study Officials
- PRINCIPAL INVESTIGATOR
James D Lewis, MD, MSCE
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2017
First Posted
February 23, 2017
Study Start
September 29, 2017
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
July 21, 2021
Results First Posted
July 21, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share