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| Name | Class |
|---|---|
| The Broad Foundation | OTHER |
| University of Chicago | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| carrageenan-free diet with placebo | Experimental | 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. |
|
| carrageenan-free diet w/ carrageenan | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carrageenan | Dietary Supplement | The intervention is the carrageenan-free diet. Supplementary carrageenan capsules will be given to mimic the carrageenan in the normal diet. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne Tobacman, M.D. | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States | ||
| University of Chicago |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. dietary intervention with no-carrageenan diet: The intervention will consist of the no-carrageenan diet. |
| FG001 | 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. carrageenan: The intervention is the carrageenan-free diet. Supplementary carrageenan capsules will be given to mimic the carrageenan in the normal diet. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. dietary intervention with no-carrageenan diet: The intervention will consist of the no-carrageenan diet. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Relapses by Group | log-rank test to test for difference in number of relapses by group | Posted | Number | relapses | up to one year of participation for each enrolled subject |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. carrageenan: The intervention is the carrageenan-free diet. Supplementary carrageenan capsules will be given to mimic the carrageenan in the normal diet. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joanne Tobacman, MD | University of Illinois at Chicago | 312-569-7826 | jkt@uic.edu |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D012008 | Recurrence |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D002351 | Carrageenan |
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| dietary intervention with no-carrageenan diet | Other | The intervention will consist of the no-carrageenan diet. |
|
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 |
| Chicago |
| Illinois |
| 60637 |
| United States |
| BG001 | 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. carrageenan: The intervention is the carrageenan-free diet. Supplementary carrageenan capsules will be given to mimic the carrageenan in the normal diet. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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|
|
| Secondary | Fecal Calprotectin (Microgram/Gram Stool) | paired t-test comparing mean values at baseline and at end of study participation by group | participants who had fecal calprotectin tests at baseline and at end of participation at one year or at time of relapse or withdrawal from study participation | Posted | Mean | Standard Deviation | micrograms/gm stool | 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 end of participation | Posted | Mean | Standard Deviation | pg/ml | change in IL-6 between baseline and up to one year of study participation |
|
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | 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. dietary intervention with no-carrageenan diet: The intervention will consist of the no-carrageenan diet. | 0 | 7 | 0 | 7 |
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| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |