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临床试验/NCT02001610
NCT02001610已完成不适用

Clinical Trial of the Viability of LAB and Bifidobacteria From Acidophilus Pearls in Human Stool Samples

University of Florida2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Change in fecal survival of probiotics

研究概览

简要总结

Commercial probiotics can be delivered in numerous forms. The two most common delivery forms are similar to the two product formats to be tested. It has been demonstrated using in vitro testing that probiotic organisms that are unprotected from gastric exposure may not survive that exposure and therefore may not remain viable throughout the rest of the GIT. (Unpublished studies conducted at SNA research facility, February, 2010.) Similar in vitro testing of Acidophilus Pearls has demonstrated the probiotic organisms in an enteric capsule will survive gastric exposure. It is anticipated that this difference in in vitro gastric survivability will translate to improved digestive tract survivability that can be demonstrated using fecal recovery techniques.

The commercial product to be tested in this clinical trial has been in the market for over 17 years. However, it is not known what effect this commercial product has on the commensal probiotic population in the gut and particularly in the lower bowel where much of probiotic benefits are believed to be largely realized. Also, it is not known what effect the commercial product has on the total commensal microbiota or fecal pH. While commercial probiotic products have been largely aimed at benefits related to improved health, they also have the potential to change overall gut microbiota (probiotics as well as all others) composition and activities. Learning what happens to the overall gut microbiota can be a helpful step in establishing the potential health benefits of the probiotic class of organisms in the test products.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adult
  • Regular and predictable bowel movement pattern
  • Willing to disclose OTC/prescription medications and dietary supplements taken during the study
  • Willing to sign comprehensive informed consent form

排除标准

  • Digestive disorders
  • Use of prescribed medications that affect bowel function or microbiota (antibiotics, pain medications, laxatives)
  • Use of dietary supplements/foods that can affect bowel function or microbiota
  • Excessive alcohol use

结局指标

主要结局

Change in fecal survival of probiotics

时间窗: Day 0 (before start of intervention), Day5-7 , Day 10-12 (end of intervention) and Day 17-19

The investigators will measure survival of the probiotics in fecal samples.

次要结局

  • GI symptoms(Day 7-9 and day 10-12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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