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

ID: NCT03058679
Status: Recruiting
Phase: N/A
Start Date: September 29, 2017
First Submitted: February 16, 2017
Last Updated: February 22, 2018
Results: N/A
Sponsors & Collaborators: University of Pennsylvania, Patient-Centered Outcomes Research Institute, Crohn's and Colitis Foundation, University of North Carolina, Chapel Hill
Location: United States
Conditions: Crohn Disease
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Study Description

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

Condition or disease Intervention/treatment Phase

Crohn Disease

Other: Diet
Other Names
N/A

Tracking Information

First Submitted DateFebruary 16, 2017
Last Update Posted DateFebruary 22, 2018
Actual Start DateSeptember 29, 2017
Anticipated Completion DateJuly 01, 2019
Actual Primary Completion DateMay 01, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Reduction in bowel inflammation [Time Frame: 6 weeks]

    Calprotectin <250 mcg/gm and >50% reduction from baseline

  • Symptomatic remission [Time Frame: 6 weeks]

    Assessed by Short Crohn's Disease Activity Index (sCDAI) - diarrhea, abdominal pain and general well being

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • 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

Not Available

Study Design

Brief TitleTrial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease
Official TitleOpen 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

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
194
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
Primary Purpose
Treatment
Conditions
Crohn Disease
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Other: Diet

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

Other Names
Study Groups/Cohorts
Specific Carbohydrate Diet

Mediterranean Style Diet

Study Arms
Active Comparator Mediterranean Style Diet
Other : Diet
food for the diet will be provided to the participants for 6 weeks

Experimental Specific Carbohydrate Diet
Other : Diet
food for the diet will be provided to the participants for 6 weeks

Arm Intervention/Treatment
Active Comparator Mediterranean Style Diet
Other : Diet
Experimental Specific Carbohydrate Diet
Other : Diet

Recruitment Information

Recruitment Status:Recruiting
Enrollment194
Completion DateJuly 01, 2019
Eligibility Criteria: Inclusion Criteria:
1. Age ≥18
2. Documented diagnosis of Crohn's disease
3. sCDAI score >175
4. Active inflammation documented by a FCP concentration >250ug/g (or >300 ug/g measured via Point-of-Care FCP testing) or high sensitivity C-reactive protein (hs-CRP)>5 mg/L measured at screening.
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 randomization
7. Start or change dose of anti-TNF agents (including infliximab, adalimumab, certolizumab pegol, golimumab) or ustekinumab within 8 weeks prior to randomization
8. Start or change dose of corticosteroids within 1 week of screening or a dose >20mg/day prednisone or equivalent*
9. Known symptomatic intestinal stricture.
10. Presence of an ostomy
11. Baseline stool frequency >4 bowel movements/day when well
12. BMI <16
13. BMI ≥40
14. Celiac disease
15. Documented C difficile colitis within four weeks of screening
16. Diabetes Mellitus requiring medication
17. Albumin<2.0mg/dl, within 4 weeks of screening (if tested as part of routine clinical care)
18. Known allergy to nuts
19. Other conditions that would be a contraindication to any of the study diets or preclude the participant from completing the study.
20. 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.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT03058679
Other Study ID Numbers
825907
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
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