NCT01497847已完成不适用
Post-Infectious Irritable Bowel Syndrome (PI-IBS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- postinfectious IBS symptoms (ROME III criteria) 1 year after travelers diarrhea episode
研究概览
简要总结
Purpose:
- identification of factors predisposing for Post-Infectious Irritable Bowel Syndrome (PI-IBS) development after an episode of traveler's diarrhea
- identification of systemic (serum) and local (biopsy) changes in infectious and immunological activity during infection and correlation with Irritable Bowel Syndrome (IBS) symptoms, persisting after traveler's diarrhea
Design:
- 4 study visits: before traveling, 2 weeks after traveling, 6 months after traveling, 12 months after traveling
- at each study visit following investigations: blood collection, stool collection, questionnaires, rectal biopsy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •traveling to South-America, Africa, South-East Asia
- •18-70 years
- •traveling for 1-10 weeks
排除标准
- •Chronic diarrhea
- •Colitis Ulcerosa
- •Morbus Chrohn
- •Coeliakie
- •Gastrointestinal malabsorption
- •microscopic colitis
- •diverticulitis
- •immune deficiency
- •use of antibiotics/corticosteroids 2 weeks before travelling
结局指标
主要结局
postinfectious IBS symptoms (ROME III criteria) 1 year after travelers diarrhea episode
时间窗: 1 year after traveling
次要结局
未报告次要终点
研究者
研究点 (1)
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