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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01065571
Other study ID # 2009-0073
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2010
Est. completion date January 2014

Study information

Verified date November 2019
Source University of Illinois at Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study hypothesis is that withdrawal of carrageenan will lead to a longer, relapse free interval in patients with ulcerative colitis.


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date January 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
carrageenan
The intervention is the carrageenan-free diet. Supplementary carrageenan capsules will be given to mimic the carrageenan in the normal diet.
Other:
dietary intervention with no-carrageenan diet
The intervention will consist of the no-carrageenan diet.

Locations

Country Name City State
United States University of Chicago Chicago Illinois
United States University of Illinois at Chicago Chicago Illinois

Sponsors (3)

Lead Sponsor Collaborator
University of Illinois at Chicago The Broad Foundation, University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Relapses by Group log-rank test to test for difference in number of relapses by group up to one year of participation for each enrolled subject
Secondary Fecal Calprotectin (Microgram/Gram Stool) paired t-test comparing mean values at baseline and at end of study participation by group one year or relapse or withdrawal compared with baseline
Secondary Serum Interleukin-6 (pg/ml) Difference in IL-6 between groups between baseline and end of study participation change in IL-6 between baseline and up to one year of study participation
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