NCT02736539撤回3 期
Clinical Trial of CBS-2004 in Prevention of Travelers' Diarrhea
Clasado Biosciences Ltd0 个研究点开始时间: 2017年4月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Assess safety and tolerance by evaluating the adverse events reported with study drug and placebo during the period of prophylaxis and through the last clinic visit.
研究概览
简要总结
This study is designed as a randomized double-blinded treatment trial among travelers' to geographical areas with moderate-severe rates of traveler's diarrhea. Travelers will be randomized to receive CBS 2004 or masked placebo to be taken daily while traveling. The test article or placebo will be taken starting 7 days prior to travel.
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
- 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
- 是
入选标准
- •Healthy subjects, 18 years old or older
- •Travel on moderate-high risk itinerary for traveler's diarrhea for minimum of 14 days and maximum of 6 weeks travel
- •Able to comply with study and follow-up procedures
- •Subjects willing and able to enter data in the diary card
- •An IRB approved informed consent form is signed and dated
- •Subjects must have adequate general health (as determined by investigators)
- •Women: Non-nursing and negative urine/serum pregnancy test with understanding through informed consent process to avoid pregnancy during the study while on the study drug. Should an individual have a documented surgical sterilization in her medical record, a pregnancy test will not be required. If a volunteer becomes pregnant during the study, the Principal Investigator (PI) will notify the study research monitor and the Institutional Review Boards (IRBs). The pregnancy outcome will be followed per IRB and other regulatory requirements.
排除标准
- •Allergy to investigational product
- •History of functional bowel disorder (including IBS)
- •Chronic intestinal disease (ulcerative colitis, crohn's disease), post vagotomy diabetic autonomic neuropathy, malabsorption, short bowel syndrome, celiac disease, bacterial overgrowth due to blind loops, pancreatitis
- •Antibiotic use within 7 days prior to enrollment (except for malaria prophylaxis excluding doxycycline)
- •Use of other probiotics or prebiotics (outside of the study product) in the prior 3-weeks or intent to use during the study period. This includes the over-the-counter preparations of probiotics, prebiotics (including inulin, lactulose) or consumption of a bio-yogurt product.
- •Lactose intolerant (allergies to dairy products).
- •Medications usage as deemed by the PI to interfere with GI function
- •Diarrheal illness within 7 days prior to enrollment
- •Subject has a concomitant disease or condition that could interfere with or for which treatment could interfere with the conduct of the study, or could in the opinion of the investigator increase the risk of adverse events (AEs) during the subject's participation in the study.
- •Use of any investigational or non-registered drug other than the study drug within 30 days preceding the study enrollment.
研究组 & 干预措施
Active
Experimental
galacto-oligosaccharides
干预措施: CBS 2004 (galacto-oligosaccharides) (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Assess safety and tolerance by evaluating the adverse events reported with study drug and placebo during the period of prophylaxis and through the last clinic visit.
时间窗: 7 weeks
To assess the effectiveness of CBS 2004 by evaluating the development of traveler's diarrhea (TD) with CBS-2004 versus placebo based on time to first unformed stool associated with a TD episode
时间窗: 7 weeks
次要结局
- Assess total number of diarrheal days(7 weeks)
- Assess the number of work days lost due to diarrhea(7 weeks)
- Assess percentages of subjects requiring treatment for diarrhea(7 weeks)
研究者
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