Antiparasitic Treatment for Returning Travelers With Chronic Diarrhea
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- improvement in gastrointestinal complaints
研究概览
简要总结
Study hypotheses is that Antiparasitic therapy in patients with chronic diarrhea after travel to a developing country, with a negative stool findings, will be significantly effective in eliminating diarrhea and other gastro-intestinal complaints compared to similar patients receiving placebo.
详细描述
It is common to encounter travelers from developing countries who suffer from persistent diarrhea after returning home. In many cases repeated stool samples are negative for bacteria, parasites and helminthes and the cause of the diarrhea is not found.
The main debate is whether this condition is a persistent parasitic infection (unidentified) or post-infectious irritable bowel syndrome.However, clinical experience suggests that some of these travelers respond to antiparasitic therapy.
This study aims to answer the question whether antiparasitic treatment in these cases is beneficial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Diarrhea (3 or more soft stools per day) for at least two weeks after a trip to a developing country in the past year
- •Stool sample negative for bacteria, parasites and helminthes at least once
- •Has not received, until now, antiparasitic or antihelminthic therapy
排除标准
- •Bloody diarrhea
- •Fever during enrolment
- •Allergy to the offered medication
研究组 & 干预措施
Placebo arm
2 placebo pills X2 /day for 2 days followed by
1 placebo Pill X2 / day for 7 days
干预措施: Placebo control (Drug)
Tinidazole and Albendazole treatment
Tinidazole 1 gram BID for 2 days followed by Albendazole 400mg BID for 7 days
干预措施: Tinidazole and Albendazole (Drug)
结局指标
主要结局
improvement in gastrointestinal complaints
时间窗: 3 months
次要结局
未报告次要终点
研究者
Prof. Eli Schwartz MD, DTMH
Director, The Center of Geographic Medicine
Sheba Medical Center