A Randomized Parallel Group Study to Evaluate the Effect of a Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Maintenance of intestinal microbiotic composition before, during and after antibiotic treatment with Augmentin 875mg
研究概览
简要总结
This is randomized, double-blind, placebo controlled, single centre; 21 days phase II clinical trial on healthy volunteers. Following baseline visit at the day of randomization, treatment with Augmentin 875mg for 7 days will be given. Concurrently and after antibiotic treatment subjects will also receive the study treatment, either probiotic or placebo. Daily Bowel Habit Diary will be completed by the subjects. The subjects will be asked to collect fecal samples for microbiological examination. The primary objective of the study is to evaluate the maintenance of intestinal microbiota composition during antibiotic treatment with Augmentin 875mg. Secondary objectives will be to evaluate the reduction in side effects associated with antibiotic use.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged 18 to 50 years.
- •Healthy as determined by laboratory results, medical history and physical exam
- •Willing to give voluntary, written, informed consent to participate in the study
排除标准
- •Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- •Body mass index ≥ 30 kg/m2
- •Average number of formed bowel movements > 3 per day or < 3 per week
- •Participation in a clinical research trial within 30 days prior to randomization
- •Use of antibiotics within 60 days prior to randomization.
- •Habitual use of pro- and/or prebiotic products.
- •Follows a vegetarian or vegan diet
- •Unstable medical conditions
- •Any evidence of acute or chronic gastrointestinal disorder
- •Alcohol use > 2 standard alcoholic drinks per day and/or alcohol or drug abuse within past year
- •Allergy or sensitivity to test product ingredients or antibiotic
- •Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
结局指标
主要结局
Maintenance of intestinal microbiotic composition before, during and after antibiotic treatment with Augmentin 875mg
时间窗: 3 weeks
Fecal samples collected during the 3 week period and stored frozen until analyses. Bacterial DNA is extracted from the samples and the microbial composition is analysed by molecular methods such as quantitative PCR.
次要结局
- The influence of probiotics on side effects associated with antibiotic use(3-weeks)