Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity
Status: | Completed |
---|---|
Conditions: | Colitis, Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/2/2016 |
Start Date: | January 2010 |
End Date: | January 2014 |
Contact: | Joanne K Tobacman, M.D. |
Email: | jkt@uic.edu |
Phone: | 312-569-7826 |
The study hypothesis is that withdrawal of carrageenan will lead to a longer, relapse free
interval in patients with ulcerative colitis.
interval in patients with ulcerative colitis.
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.
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.
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
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University of Chicago One of the world's premier academic and research institutions, the University of...
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University of Illinois at Chicago A major research university in the heart of one of...
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