NCT01005849终止4 期
A Parallel, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Probiotic Formula in the Prevention of Traveler's Diarrhea
Lallemand SAS1 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2009年10月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Occurence of traveler's diarrhea
研究概览
简要总结
The present study is designed to evaluate the effect of a mixture of probiotics on the prevention of traveler's diarrhea (TD) in subjects who travel to a country with a high risk for developing TD. Subjects will be asked to take one capsule containing a mixture of probiotics or a placebo capsule a day, within the week before departure, during the travel and up to 3 days after return. They will note the following outcomes in a diary: occurence of diarrhea, number and consistency of stools, duration of the diarrhea, presence of diarrhea-related symptoms and need for rescue medication.
The present study will examine if the use of the probiotics capsule reduces the occurence of traveler's diarrhea as compared to the placebo capsule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, 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
- 是
入选标准
- •Male and female subjects aged 18 or over. Upper age limit set by subject's ability to participate in the study;
- •Subject must give written informed consent;
- •Plan to travel to a geographic area with high risk of TD with a travel duration between 12 and 14 days;
- •Subjects must be willing to refrain from using anti-diarrheal medications or antibiotics during the study period, unless they become clinically indicated in which case a rescue regimen can be administered;
- •Subjects willing to refrain from eating yoghurt and taking other probiotics during the study;
- •Female subjects of child-bearing potential must agree to use adequate birth control during the study period. This will be defined as hormonal contraception or a double barrier-method.
排除标准
- •Subjects who have been previously treated with PROTECFLOR® or who have participated in previous Lallemand-sponsored studies;
- •Subjects who have been born in a developing country.
- •Subjects with a history of substance or alcohol abuse or any other psychological condition that may, in the investigator's opinion, adversely affect their co-operation with the study;
- •Subjects who receive a cholera vaccine
- •Subjects with chronic diarrhea;
- •Subjects with chronic disease such as irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD) or ulcerative colitis (UC) ;
- •Subjects with gastrointestinal (GI) surgery during the last 3 months;
- •Subjects who took systemic antibiotic 15 days or less prior to the study;
- •Subjects with immunodeficiency's or immune suppression;
- •Subjects being treated for cancer with radiotherapy and/or chemotherapy;
- •Subjects with organ transplants;
- •Subjects treated with immunosuppressant drugs;
- •Subjects receiving another probiotic preparations or having received probiotic preparations within the last 15 days;
- •Subjects with tube feeding, ileostomy and colostomy;
- •Subjects diagnosed Clostridium difficile colitis within the last 3 months;
- •Women who are pregnant, or who will not consent to using adequate birth control during the study period;
- •Women who are breastfeeding.
结局指标
主要结局
Occurence of traveler's diarrhea
时间窗: 3 weeks
次要结局
- Number and consistency of stools (normal, soft or unformed)(3 weeks)
- Duration of traveler's diarrhea if occurred (# days)(3 weeks)
- Presence of symptoms associated with TD (cramps, nausea, fever, blood in the stools, vomiting, bloating, flatulence, visceral pain)(3 weeks)
- Need for rescue medication(3 weeks)
研究者
研究点 (1)
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