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

Crohn Disease Clinical Trial

— DINE-CD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03058679
• Other study ID #: 825907
• Status: Completed
• Phase: N/A
• Start date: September 29, 2017
• Est. completion date: March 1, 2020

Study information

• Verified date: June 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	Atlanta Gastroenterology	Atlanta	Georgia
United States	Emory University	Atlanta	Georgia
United States	University of Maryland Baltimore	Baltimore	Maryland
United States	Boston Children's Hospital	Boston	Massachusetts
United States	The University of North Carolina	Chapel Hill	North Carolina
United States	Atrium Health (formerly Carolinas HealthCare System)	Charlotte	North Carolina
United States	Clinical Research Institute of Michigan	Chesterfield	Michigan
United States	University of Chicago	Chicago	Illinois
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 Colorado Denver	Denver	Colorado
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	Northwestern University	Evanston	Illinois
United States	Indiana University Health University Hospital	Indianapolis	Indiana
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	The University of Louisville	Louisville	Kentucky
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	The University of Minnesota	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Lenox Hill Hospital	New York	New York
United States	NYU Langone Medical Center	New York	New York
United States	Weill Cornell - NewYork Presbyterian	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Minnesota Gastroenterology, P.A	Plymouth	Minnesota
United States	Lifespan Health System	Providence	Rhode Island
United States	Mayo Clinic - Rochester	Rochester	Minnesota
United States	University of Utah	Salt Lake City	Utah
United States	UCSF Colitis and Crohn's Disease Center	San Francisco	California
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Troy Gastroenterology	Troy	Michigan
United States	University of Arizona	Tucson	Arizona
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
University of Pennsylvania	Crohn's and Colitis Foundation, Patient-Centered Outcomes Research Institute, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Percentage of Participants That Reached Clinical Remission at Week 6	Assessed by the CDAI - CDAI <150	6 weeks
Secondary	Percentage of Participants With a Reduction in Systemic Inflammation at Week 6	reduction in high-sensitivity CRP (hsCRP) to <5 mg/L and >50% reduction from screening among those with screening hsCRP >5mg/L	6 weeks