Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease (DINE-CD)

• ClinicalTrials.gov Identifier: NCT03058679
• Recruitment Status: Active, not recruiting
• First Posted: February 23, 2017
• Last Update Posted: May 12, 2020
• Sponsor: University of Pennsylvania
• Collaborators: Patient-Centered Outcomes Research Institute; Crohn's and Colitis Foundation; University of North Carolina, Chapel Hill
• Information provided by (Responsible Party): University of Pennsylvania

Tracking Information

• First Submitted Date: February 16, 2017
• First Posted Date: February 23, 2017
• Last Update Posted Date: May 12, 2020
• Actual Study Start Date: September 29, 2017
• Actual Primary Completion Date: March 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 12, 2017)

• Symptomatic remission [ Time Frame: 6 weeks ]
  Assessed by Short Crohn's Disease Activity Index (sCDAI) - diarrhea, abdominal pain and general well being
• Reduction in bowel inflammation [ Time Frame: 6 weeks ]
  Calprotectin <250 mcg/gm and >50% reduction from baseline

Original Primary Outcome Measures (submitted: February 16, 2017)

• Symptomatic remission [ Time Frame: 6 weeks ]
  Assessed by Short Crohn's Disease Activity Index - diarrhea, abdominal pain and general well being
• Reduction in bowel inflammation [ Time Frame: 6 weeks ]
  Calprotectin <250 mcg/gm and >50% reduction from baseline

Current Secondary Outcome Measures (submitted: February 16, 2017)

• Clinical remission [ Time Frame: 6 weeks ]
  Assessed by the Harvey Bradshaw Index
• Reduction in systemic inflammation [ Time Frame: 6 weeks ]
  hsCRP < 5mg/L >50% reduction from baseline

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease
• Official Title: Open Label, Randomized, Multicenter, Comparative Effectiveness Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients With Crohn's Disease
• 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: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Crohn Disease

Intervention

Other: Diet

food for the diet will be provided to the participants for 6 weeks

Study Arms

• Experimental: Specific Carbohydrate Diet
  Intervention: Other: Diet
• Active Comparator: Mediterranean Style Diet
  Intervention: Other: Diet

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: February 16, 2017): 194
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2021
• Actual Primary Completion Date: March 1, 2020 (Final data collection date for primary outcome measure)

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-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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03058679
• Other Study ID Numbers: 825907
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: University of Pennsylvania
• Study Sponsor: University of Pennsylvania

Collaborators

• Patient-Centered Outcomes Research Institute
• Crohn's and Colitis Foundation
• University of North Carolina, Chapel Hill

Investigators

• Principal Investigator: James D Lewis, MD, MSCE; University of Pennsylvania

• PRS Account: University of Pennsylvania
• Verification Date: May 2020