NCT04596605已完成不适用
Gastrointestinal Tolerance Assessment of T2309
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Gastrointestinal Tolerance assessment
研究概览
简要总结
Gastrointestinal Tolerance assessment of T2309 compared to a food supplement in 50 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent signed and dated
- •Volunteer with no history of gastrointestinal disorders
- •Volunteer agreeing not to consume a food supplement other than IP during the study period
- •Registered, or agreeing to be registered, in the National Registry of Healthy Volunteers
排除标准
- •Any known or suspected hypersensitivity or allergy
- •History of or active severe chronic disease or relevant systemic condition incompatible with the study
- •Pregnancy or breast-feeding or have planned pregnancy in the next 4 months
- •Childbearing potential woman neither surgically sterilized nor using an adequate contraception
- •Inability of the subject to understand the study procedures or to give informed consent
- •Non-compliant subject
- •Participation in this study at the same time as another clinical investigation/study
- •Subject having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros
- •Subject being institutionalized because of legal or regulatory order, inmate of psychiatric wards, prison or state institutions, or employee of the study site or of the Sponsor's company
- •Subject not covered by the government health care scheme of the country in which he/she is living
- •Subject with previous, current or anticipated prohibited treatment
结局指标
主要结局
Gastrointestinal Tolerance assessment
时间窗: 12-week
Change from baseline in the mean of the daily composite score of gastrointestinal tolerance assessed with the Bristol Stool Scale (BSS) (composite score of stool frequency and consistency) and 10-point Likert scales filled (sum of the ratings of the 4 gastrointestinal symptoms scores) daily for 1 week prior to the completion of the 12-week treatment period (expressed in arbitrary unit/day (a.u./day), range 0-50)
次要结局
- Each component of the composite score of gastrointestinal tolerance(6 weeks and 12 weeks)
- Acceptability(6 weeks and 12 weeks)
- Composite score of gastrointestinal tolerance(6 weeks)
研究者
研究点 (1)
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