NCT00737412已完成3 期
A Double-blind, Randomized, Placebo Controlled, Multicenter Study of the Efficacy of BIO-K+ CL1285® Prophylaxis in the Prevention of Traveler's Diarrhea in Adults.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 277
- 试验地点
- 8
- 主要终点
- To determine the efficacy of Bio-K+ CL1285 RX® in reducing traveler's diarrhea by comparing the incidence of diarrhea in travelers during their stay abroad and upon their return to Canada, following either BIO-K+CL1285 RX® or placebo prophylaxis.
研究概览
简要总结
The purpose of this study is to determine the efficacy of Bio-K+ CL1285 in reducing traveler's diarrhea.
详细描述
Determine efficacy of Bio-K+ CL1285 in reducing Traveler's Diarrhea by comparing the incidence of diarrhea in travelers during their stay abroad and upon their return to Canada following either Bio-K+ CL-1285 OR placebo prophylaxis.
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, Care Provider, Investigator)
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 or female subjects over 18 years of age traveling to Mexico, Central America, South America and Caribbean Islands as direct destinations or on cruises to the same destinations.
- •The trips last a minimum of 7 days and a maximum of 21 days.
- •Women of child bearing capacity who are not pregnant at the moment of screening (pregnancy test done on-site) and agree to use an acceptable form of birth control for the duration of the study (e.g. Condom, oral contraceptives, etc.) are allowed to participate.
排除标准
- •active diarrhea;
- •pregnancy; breastfeeding
- •3 diarrheic episodes within 24 hours in the 15 days preceding the date of the departure;
- •antibiotic treatment during the last 15 days or ongoing treatment at the time of departure;
- •consumption of fermented milk, yogourt or probiotics probiotics in the 15 days preceding the date of the departure;
- •immunosuppressed state or any health condition being susceptible to decompensate during the study (including malignant hemo-pathologies, AIDS, bone marrow transplant or organ transplant).
- •active radiotherapy or chemotherapy as cancer treatment
- •the administration of an ETEC/cholera vaccine or any other diarrhea vaccine in the three months prior to study initiation
- •an active, non-controlled intestinal disease;
- •ileostomy, jejunostomy or colostomy
- •concomitant participation in another clinical trial
- •mental or other conditions, or language barriers rendering the subject unable to understand the nature, scope, and possible consequences of the study or complete the self-administered questionnaires;
- •subject unlikely to comply with protocol, e.g., uncooperative attitude, and unlikelihood of completing the study,
- •allergies to any ingredients in the study product (active product or placebo)
- •current use of illicit drug and alcohol abuse
结局指标
主要结局
To determine the efficacy of Bio-K+ CL1285 RX® in reducing traveler's diarrhea by comparing the incidence of diarrhea in travelers during their stay abroad and upon their return to Canada, following either BIO-K+CL1285 RX® or placebo prophylaxis.
时间窗: March 2008 to April 2009
次要结局
- To compare the severity of diarrhea in travelers during their stay abroad and upon their return to Canada, following either BIO-K+CL1285 RX® or placebo prophylaxis.(March 2008 to April 2009)
- To compare the safety profile of BIO-K+CL1285 RX® to that of placebo(March 2008 to April 2009)
- To compare the physician and traveler satisfaction following daily prophylaxis with either BIO-K+CL1285 RX® or placebo(March 08 to April 09)
- To evaluate and compare the health economic impact of daily prophylaxis with BIO-K+CL1285 RX®.(March 08 to April 09)
研究者
研究点 (8)
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