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临床试验/NCT01065571
NCT01065571已完成不适用

Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity

University of Illinois at Chicago4 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2010年1月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joanne Kramer Tobacman

Associate Professor of Clinical Medicine

University of Illinois at Chicago

研究点 (4)

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