NCT06385639招募中不适用
A Double-blind, Randomized Clinical Study, Compared With Placebo to Assess the Efficacy and Safety of a Probiotic Product Containing Four Probiotic Strains to Support Digestive Environment and Homeostasis of Gut Microbiota
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Intestinal health
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of the probiotic product as an everyday gut health product in supporting digestive environment and homeostasis of gut microbiota.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female subject age 18-60 years at screening
- •Healthy subject according to investigator judgement based on screening data
- •Subjects must be either of non-childbearing potential, or if of childbearing potential, they must be abstinent or have practiced adequate contraception for the entire study
- •Subjects who have not smoked in the past 1 month prior to screening
- •Subjects with a healthy and balanced diet, including adequate fiber intake in their food consumption
- •Subject or subject's legally acceptable representatives have the ability to comply with the trial protocol
- •Signed informed consent from the subjects or subject's legally acceptable representatives (must be obtained before any trial related activities)
排除标准
- •History of presence of diabetes, immunodeficiency disorders, or chronic illness
- •Regular use of medications known to affect the gastrointestinal system or alter gut microbiota composition, including but not limited to antibiotics, and immunosuppressants
- •Have continuous, daily use of probiotic or probiotic containing products within 1 month prior to randomization
- •Pregnant, planning a pregnancy or lactating female (urinary pregnancy test will be applied to female subjects at screening)
- •Change type of diet during study
- •Any known allergy or intolerance to any of the ingredients in the formulation of the product under study
- •History of drug, alcohol or other substance abuse, or other factors that limit their ability to cooperate during the study
- •History of or presence of eating disorder
- •Subject whose condition does not make them eligible to the study, according to the investigator
结局指标
主要结局
Intestinal health
时间窗: 10 days
Changes in short-chain fatty acid (SCFA) from baseline to day 10
次要结局
未报告次要终点
研究者
研究点 (2)
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