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

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ClinicalTrials.gov Identifier: NCT03058679

Recruitment Status : Recruiting

First Posted : February 23, 2017

Last Update Posted : May 9, 2019

See Contacts and Locations

Sponsor:

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 ^ICMJE

February 16, 2017

First Posted Date ^ICMJE

February 23, 2017

Last Update Posted Date

May 9, 2019

Actual Study Start Date ^ICMJE

September 29, 2017

Estimated Primary Completion Date

January 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ^ICMJE

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

Change History

Complete list of historical versions of study NCT03058679 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Crohn Disease

Intervention ^ICMJE

Other: Diet

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

Study Arms ^ICMJE

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

194

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

January 2020

Estimated Primary Completion Date

January 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria

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

Exclusion Criteria

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-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-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
Celiac disease
Documented C difficile colitis within four weeks of screening
Diabetes Mellitus requiring medication
Albumin<2.0mg/dl, within 4 weeks of screening (if tested as part of routine clinical care)
Known allergy to tree nuts or peanuts
Other conditions that would be a contraindication to any of the study diets or preclude the participant from completing the study.
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 ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Maria Escobar	215-746-4218	escobarm@pennmedicine.upenn.edu
Contact: Lisa C Nessel, MSS, MLSP	215-573-6003	nessel@pennmedicine.upenn.edu

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT03058679

Other Study ID Numbers ^ICMJE

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 ^ICMJE

Plan to Share IPD:

Responsible Party

University of Pennsylvania

Study Sponsor ^ICMJE

University of Pennsylvania

Collaborators ^ICMJE

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

Investigators ^ICMJE

Principal Investigator:

James D Lewis, MD, MSCE

University of Pennsylvania

PRS Account

University of Pennsylvania

Verification Date

May 2019

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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