NCT06728098招募中不适用
Safety and Tolerability Evaluation of Heat-Inactivated Akkermansia Muciniphila Akk11: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Changes in stool quality
研究概览
简要总结
This is a randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of Akkermansia muciniphila Akk11 in healthy adult.
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
- Double (Participant, Investigator)
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 subject or subject's legally acceptable representatives (must be obtained before any trial related activities).
排除标准
- •History of or 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 probiotics 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
Changes in stool quality
时间窗: 30 days
Stool consistency (using the Bristol Stool Scale) from baseline to day 30. The Bristol Stool Scale is a tool to assess gut health by classifying feces into seven categories based on shape and consistency: types 1-2 indicate constipation, 3-4 are normal, and 5-7 suggest diarrhea.
次要结局
未报告次要终点
研究者
研究点 (2)
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