ChiCTR2400089534已完成4 期
Resistome of gut microbiota and modulation in healthy Hong Kong population
The Hong Kong Food and Health Bureau, Health and Medical Research Fund (Grant#18170082, PI:MI)1 个研究点 分布在 1 个国家开始时间: 2019年3月1日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 试验地点
- 1
- 主要终点
- Quantitation of probiotic bacteria and their persistence in the gut
研究概览
简要总结
- To evaluate probiotics survival and persistence in the gut;
- To evaluate the presence and degree of gut microbiota restoration with probiotics;
- To evaluate the inhibition of antibiotic resistance through probiotics.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- None
入排标准
- 年龄范围
- 18 至 50（—）
- 性别
- All
入选标准
- •Participated in a previous entitled Modulation of gut microbiota with probiotics: a pilot study (IRB No. 2018.116);
- •Aged 18 to 50 years old (Both male and female);
- •Able to comply with study requirements and to provide informed consent;
- •Agreement to comply with approved methods of contraception during the period of active study.
排除标准
- •Any chronic or recurrent illness requiring follow-up or medication;
- •History of organ transplantation or immunosuppression;
- •A history of allergy or hypersensitivity to the probiotic bacteria, placebo or antimicrobial agent eg. augmentin, amoxicillin-clavulanate, amoxicillin or other penicillins, or cephalosporins;
- •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);
- •Oral or systemic antibacterial/ antifungal or antiviral therapy during the 3 months prior to study enrollment;
- •New prescription medications during the 4 weeks prior to study enrollment;
- •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);
- •Prior gastrointestinal surgery (apart from appendectomy or cholecystectomy);
- •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;
- •Current smoker;
- •Regular intake of medication (birth control pills excepted);
- •History of structural heart diseases such as valve abnormality, valve replacement or endocarditis (S. Doron & David R. Snydman, 2015);
- •Patient with a central venous catheter (S. Doron & David R. Snydman, 2015).
研究组 & 干预措施
A
B
C
D
结局指标
主要结局
Quantitation of probiotic bacteria and their persistence in the gut
时间窗: Days 0, 7, 14, 21, 104
Evaluate the changes in composition of gut microbiota community composition
时间窗: Days 0, 7, 14, 21, 104
The restoration of the gut phyla during course of antibiotic with concomitant probiotic in Hong Kong healthy adults
次要结局
- Evaluate the abundance and changes of antimicrobial resistance genes ARGs(Days 0, 7, 14, 21, 104)
- The tolerability of the probiotic(s) in subjects taking antibiotic in Hong Kong
- The changes to ‘resistome’ in antibiotic use with concomitant use of probiotics
研究者
研究点 (1)
Loading locations...
相似试验
招募中
3 期
Using probiotics to reduce the side effects and toxicities caused by chemoradiation treatment in patients of esophageal, colon, rectal and anal canal cancer.CTRI/2024/03/064552Indian Council of Medical Research360
招募中
不适用
The Impact of Probiotic Intervention on the Gut Microbiota and Bowel FunctionNCT07369830Huashan Hospital156
尚未招募
2 期
The Effect of Probiotics on Gut Microbiota Changes in Healthy Chinese Adults During Short-Term European Travel: A Randomised, Double-Blind, Placebo-Controlled Clinical TrialNCT07384260Min-Tze LIONG40
尚未招募
不适用
Probiotic Intervention in ConstipationNCT07462494Wecare Probiotics Co., Ltd.30
尚未招募
不适用
Probiotics, Antibiotics and the Post-Antibiotic MicrobiotaNCT07425704Cultech Ltd50