Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Number of Relapses by Group
研究概览
简要总结
The study hypothesis is that withdrawal of carrageenan will lead to a longer, relapse free interval in patients with ulcerative colitis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ulcerative colitis
- •In remission
- •Required corticosteroids to induce remission
- •Able to make food choices and follow diet
排除标准
- •Not able to make food choices
结局指标
主要结局
Number of Relapses by Group
时间窗: up to one year of participation for each enrolled subject
log-rank test to test for difference in number of relapses by group
次要结局
- Fecal Calprotectin (Microgram/Gram Stool)(one year or relapse or withdrawal compared with baseline)
- Serum Interleukin-6 (pg/ml)(change in IL-6 between baseline and up to one year of study participation)
研究者
Joanne Kramer Tobacman
Associate Professor of Clinical Medicine
University of Illinois at Chicago
