A Prospective, Open-Label, Single-Arm, Single-Centre Clinical study to evaluate the safety of Lactic acid bacteria (Lactobacillus fermentum HEM792) in healthy Adults.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
This is a prospective, open-label, single-arm, single-centre clinical study designed to evaluate the safety and tolerability of the probiotic strain Lactobacillus fermentum HEM792 in healthy adults. L. fermentum is a naturally occurring beneficial bacterium commonly found in the human gut and fermented foods, with recognized probiotic properties such as supporting gut health, immune function, and antioxidant activity. While Lactobacillus species are generally considered safe, this study will specifically assess the safety of high-dose administration (100 billion CFU per day). Safety will be evaluated through monitoring of adverse events, vital signs, and laboratory parameters to generate robust clinical data supporting its use in healthy adult populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 19.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Eligible participants must meet all of the following criteria -Healthy adults of both genders aged 19 to 75 years -Able and willing to provide written informed consent before any study related procedures -Willing to follow the study requirements including scheduled visits laboratory tests and use of the study product -Able and willing to maintain a participant diary to record daily product intake tolerability and any adverse events -Participants with clinical laboratory values at screening that are within normal limits or considered acceptable by the investigator.
排除标准
- •Participation in another clinical trial within the past 3 months -History of psychiatric illness or any condition that may affect study compliance -Known allergy or intolerance to probiotics or any component of the study product -Current use of investigational products probiotic supplements or probiotic rich foods that cannot be stopped during the study period -Any clinically significant medical condition or abnormal laboratory value that in the opinion of the investigator may increase risk or affect study assessments -Pregnant or breastfeeding women -Participants who are immunocompromised have chronic infections or are receiving immunosuppressive therapy -Any other condition that in the opinion of the investigator makes the participant unsuitable for the study.
研究者
Dr Manjunath U
Currex Hospital