Carrageenan
Dietary SupplementThe intervention is the carrageenan-free diet. Supplementary carrageenan capsules will be given to mimic the carrageenan in the normal diet.
NCT Number: NCT01065571
The study hypothesis is that withdrawal of carrageenan will lead to a longer, relapse free interval in patients with ulcerative colitis.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
University of Chicago, Chicago, Illinois, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention is the carrageenan-free diet. Supplementary carrageenan capsules will be given to mimic the carrageenan in the normal diet.
The intervention will consist of the no-carrageenan diet.
Time frame: up to one year of participation for each enrolled subject
log-rank test to test for difference in number of relapses by group
Time frame: one year or relapse or withdrawal compared with baseline
paired t-test comparing mean values at baseline and at end of study participation by group
Time frame: change in IL-6 between baseline and up to one year of study participation
Difference in IL-6 between groups between baseline and end of study participation
University of Illinois at Chicago
Other
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