Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity

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

Detailed Description
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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.

Official Title
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Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Dietary Supplement: carrageenan
* Other: dietary intervention with no-carrageenan diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: carrageenan-free diet with placebo<br>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<br>* The intervention will consist of the no-carrageenan diet.<br>|
| Active Comparator: carrageenan-free diet w/ carrageenan<br>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<br>* The intervention is the carrageenan-free diet. Supplementary carrageenan capsules will be given to mimic the carrageenan in the normal diet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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relapse, carrageenan, inflammation