ChiCTR2400089534
结束
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2024-09-10
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Resistome of gut microbiota and modulation in healthy Hong Kong population
Resistome of gut microbiota and modulation in healthy Hong Kong population
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.
随机平行对照
Ⅳ期
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.
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.
The Hong Kong Food and Health Bureau, Health and Medical Research Fund (Grant#18170082, PI:MI)
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15
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2019-03-01
2021-03-01
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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.；
登录查看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).；
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