Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity
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|ClinicalTrials.gov Identifier: NCT01065571|
Recruitment Status : Unknown
Verified August 2013 by Joanne Kramer Tobacman, University of Illinois at Chicago.
Recruitment status was: Recruiting
First Posted : February 9, 2010
Last Update Posted : August 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Dietary Supplement: carrageenan Other: dietary intervention with no-carrageenan diet||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||January 2014|
Experimental: carrageenan-free diet with placebo
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.
Other: dietary intervention with no-carrageenan diet
The intervention will consist of the no-carrageenan diet.
Active Comparator: carrageenan-free diet w/ carrageenan
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.
Dietary Supplement: carrageenan
The intervention is the carrageenan-free diet. Supplementary carrageenan capsules will be given to mimic the carrageenan in the normal diet.
- Time to relapse [ Time Frame: one year ]
- laboratory parameters of inflammation [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01065571
|Contact: Joanne K Tobacman, M.D.||email@example.com|
|United States, Illinois|
|University of Illinois at Chicago||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Joanne K. Tobacman, M.D. 312-569-7826 firstname.lastname@example.org|
|Principal Investigator: Joanne K. Tobacman, M.D.|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Stephen B. Hanauer, M.D. 773-702-1466 email@example.com|