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

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基本信息

登记号

ChiCTR2400089534

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2024-09-10

临床申请受理号

靶点

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

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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

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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

目标入组人数

实际入组人数

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

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

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试验机构

The Chinese University of Hong Kong

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