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Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
carrageenan
dietary intervention with no-carrageenan diet
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ulcerative Colitis focused on measuring relapse, carrageenan, inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ulcerative colitis
  • Adult
  • In remission
  • Required corticosteroids to induce remission
  • Able to make food choices and follow diet

Exclusion Criteria:

  • Not able to make food choices

Sites / Locations

  • University of Illinois at Chicago
  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

carrageenan-free diet with placebo

carrageenan-free diet w/ carrageenan

Arm Description

This is the experimental arm in which subjects will be on a no-carrageenan diet and receive placebo capsules. This will test whether the no carrageenan diet leads to longer relapse-free interval for patients with ulcerative colitis.

The carrageenan-free diet with carrageenan supplement will mimic the carrageenan normally consumed in the diet. The study will permit blinded comparison of carrageenan-free vs. carrageenan consumption.

Outcomes

Primary Outcome Measures

Number of Relapses by Group
log-rank test to test for difference in number of relapses by group

Secondary Outcome Measures

Fecal Calprotectin (Microgram/Gram Stool)
paired t-test comparing mean values at baseline and at end of study participation by group
Serum Interleukin-6 (pg/ml)
Difference in IL-6 between groups between baseline and end of study participation

Full Information

First Posted
February 4, 2010
Last Updated
November 20, 2019
Sponsor
University of Illinois at Chicago
Collaborators
The Broad Foundation, University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT01065571
Brief Title
Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity
Official Title
Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
The Broad Foundation, University of Chicago

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study hypothesis is that withdrawal of carrageenan will lead to a longer, relapse free interval in patients with ulcerative colitis.
Detailed Description
This study will evaluate the interval to relapse in patients with ulcerative colitis. The patients will be adults, who have been in remission for at least one month. They will have previously required corticosteroids to induce remission. Subjects will be instructed in a no-carrageenan diet and required to follow this diet for the duration of their participation in the clinical study. They will be randomized to receive either placebo capsules or capsules containing carrageenan 100 mg. In this way, the study will be a double blind study of no-carrageenan vs. carrageenan. Main study outcome is the interval to relapse. Since ulcerative colitis is associated with relapses, relapse is anticipated. Other outcome measures will include scores on questionnaires, including the SSCAI and the SIDBQ, and laboratory measurements of inflammation. Subjects will participate for one year or until relapse, with study visits every three months and telephone contacts every two weeks. After three months, participants will increase to two capsules daily, of either placebo or carrageenan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
relapse, carrageenan, inflammation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
carrageenan-free diet with placebo
Arm Type
Experimental
Arm Description
This is the experimental arm in which subjects will be on a no-carrageenan diet and receive placebo capsules. This will test whether the no carrageenan diet leads to longer relapse-free interval for patients with ulcerative colitis.
Arm Title
carrageenan-free diet w/ carrageenan
Arm Type
Active Comparator
Arm Description
The carrageenan-free diet with carrageenan supplement will mimic the carrageenan normally consumed in the diet. The study will permit blinded comparison of carrageenan-free vs. carrageenan consumption.
Intervention Type
Dietary Supplement
Intervention Name(s)
carrageenan
Intervention Description
The intervention is the carrageenan-free diet. Supplementary carrageenan capsules will be given to mimic the carrageenan in the normal diet.
Intervention Type
Other
Intervention Name(s)
dietary intervention with no-carrageenan diet
Intervention Description
The intervention will consist of the no-carrageenan diet.
Primary Outcome Measure Information:
Title
Number of Relapses by Group
Description
log-rank test to test for difference in number of relapses by group
Time Frame
up to one year of participation for each enrolled subject
Secondary Outcome Measure Information:
Title
Fecal Calprotectin (Microgram/Gram Stool)
Description
paired t-test comparing mean values at baseline and at end of study participation by group
Time Frame
one year or relapse or withdrawal compared with baseline
Title
Serum Interleukin-6 (pg/ml)
Description
Difference in IL-6 between groups between baseline and end of study participation
Time Frame
change in IL-6 between baseline and up to one year of study participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ulcerative colitis Adult In remission Required corticosteroids to induce remission Able to make food choices and follow diet Exclusion Criteria: Not able to make food choices
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne Tobacman, M.D.
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

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Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity

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