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【ChiCTR2400089534】Resistome of gut microbiota and modulation in healthy Hong Kong population

基本信息
登记号

ChiCTR2400089534

试验状态

结束

药物名称

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药物类型

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规范名称

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首次公示信息日的期

2024-09-10

临床申请受理号

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靶点

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适应症

None

试验通俗题目

Resistome of gut microbiota and modulation in healthy Hong Kong population

试验专业题目

Resistome of gut microbiota and modulation in healthy Hong Kong population

申办单位信息
申请人联系人
申请人名称
联系人邮箱
联系人邮编

联系人通讯地址
临床试验信息
试验目的

1. To evaluate probiotics survival and persistence in the gut; 2. To evaluate the presence and degree of gut microbiota restoration with probiotics; 3. To evaluate the inhibition of antibiotic resistance through probiotics.

试验分类
试验类型

随机平行对照

试验分期

Ⅳ期

随机化

Subjects were randomised into groups A, B, C, D by the research assistant involved in the recruitment process. Once the number of subjects for the group has been filled (n = 15), the group is no longer available for randomisation. Recruitment is stopped once all groups have been filled.

盲法

Products were open-labelled commercially available probiotics. Subjects understood which probiotic they were taking in and a briefing on how to take the probiotics was made.

试验项目经费来源

The Hong Kong Food and Health Bureau, Health and Medical Research Fund (Grant#18170082, PI:MI)

试验范围

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目标入组人数

15

实际入组人数

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第一例入组时间

2019-03-01

试验终止时间

2021-03-01

是否属于一致性

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入选标准

1. Participated in a previous entitled Modulation of gut microbiota with probiotics: a pilot study (IRB No. 2018.116); 2. Aged 18 to 50 years old (Both male and female); 3. Able to comply with study requirements and to provide informed consent; 4. Agreement to comply with approved methods of contraception during the period of active study.;

排除标准

1. Any chronic or recurrent illness requiring follow-up or medication; 2. Pregnancy; 3. History of organ transplantation or immunosuppression; 4. A history of allergy or hypersensitivity to the probiotic bacteria, placebo or antimicrobial agent eg. augmentin, amoxicillin-clavulanate, amoxicillin or other penicillins, or cephalosporins; 5. History of any severe allergic reaction (requiring hospital admission and/or the administration of parenteral medication or associated with dyspnea, wheezing, hypotension, loss of consciousness); 6. Oral or systemic antibacterial/ antifungal or antiviral therapy during the 3 months prior to study enrollment; 7. New prescription medications during the 4 weeks prior to study enrollment; 8. Over-the-counter medications or supplements that are known to alter gut function or microflora (i.e., acid anti-secretory drugs, probiotics, laxatives) during the 4 weeks prior to study enrollment (except articles of the Phase 1 study); 9. Prior gastrointestinal surgery (apart from appendectomy or cholecystectomy); 10. Any condition or personal circumstance that, in the opinion of the investigator, renders the subject unlikely or unable to comply with the full study protocol; 11. Current smoker; 12. Regular intake of medication (birth control pills excepted); 13. History of structural heart diseases such as valve abnormality, valve replacement or endocarditis (S. Doron & David R. Snydman, 2015); 14. Patient with a central venous catheter (S. Doron & David R. Snydman, 2015).;

研究者信息
研究负责人姓名
试验机构

The Chinese University of Hong Kong

研究负责人电话
研究负责人邮箱
研究负责人邮编

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联系人通讯地址
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