NCT06988514已完成不适用
A Single-center, Exploratory, Interventional Clinical Study for Stool Samples Collection in Healthy Participants to Use and Further Advance Some Danone Research Applications
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Collect enough acceptable stool samples
研究概览
简要总结
Purpose of this study is to collect stool samples from healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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 and female participants aged between 18-60 years.
- •18.5 ≤ BMI < 30 kg/m
- •Overtly healthy as determined by the Investigator.
- •Regular bowel movements and a mean stool consistency of 3-5 in Bristol Stool Form Scale (BSFS) during the past week.
- •Collect their stool samples and delivered at site.
- •Speak and read in French.
- •Comply with the study protocol and to commit to the instructions and restrictions.
- •Refrain from any fermented dairy products throughout the study conduct.
- •Refrain from prebiotic, probiotic or synbiotic supplements during the study.
- •Maintain the dose of other consumed supplements during the study.
- •Limit alcohol consumption to ≤ 2 units (i.e., standard glasses) of alcohol per day with a maximum of 10 units per week during the study.
- •Not change substantially their smoking habits during the study.
- •Written informed consent Form (ICF) signed by the participant.
- •No substantial changes in diet and/or physical activity and/or lifestyle habits, defined as start or stop new foods and/or supplements and/or sports and/or daily habits (i.e., travel, sleeping habits) during the study.
- •Have a personal electronic device compatible and connectable to internet to access the web based MyFood24 site when required.
- •Covered by social security or similar system.
- •Agree to be registered in the National biomedical research file for volunteers.
排除标准
- •Any ongoing metabolic disease, inflammatory disease, hepato-gastrointestinal dis-ease or complications, psychiatric or neurological disorder or other diagnosed by a physician.
- •Any invasive diagnostic and/or therapeutic procedure related to digestion within the past 4 weeks or plan for a digestive surgery during the study, including dental sur-gery, (i.e., from the onset of the wash-out period to the last data collection).
- •General anesthesia during the past 4 weeks or planned during the course of the study.
- •For women in childbearing potential, pregnancy or breastfeeding or plan for preg-nancy during the study.
- •Use of medication that affects the gastrointestinal (GI) function or use of stomach medication within the past 4 weeks or plan to use of any of these during the study.
- •Non-incidental use of > 4 paracetamol tablets (500 mg), nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin ≤ 2 weeks before the screening visit (V1) or plan of use during the study (if needed, incidental use of ≤ 4 tablets of paracetamol, NSAIDs or aspirin per 2-week period (i.e. ≤ 4 tablets during the refrain period, ≤ 4 tab-lets during the study).
- •Antibiotic, antifungal, antiviral or antiparasitic medication within the past 6 months.
- •Use of any soft drugs, cannabidiol (CBD), plants medicines and/or hard drugs during the study.
- •Participant of another study with investigational or marketed products which could the gut microbiota within the past 4 weeks or plan to participate in such a study dur-ing the study.
- •Participant under guardianship, curatorship, person under judicial protection, family empowerment or future protection mandate.
- •Employees and/or children/family members or relatives of employees of Danone or the participating sites such as medical, pharmacy, dental and nursing students, sub-ordinate hospital and laboratory personnel, employees of the Investigator or of the Sponsor, members of the armed forces, and persons kept in detention.
- •Having received, during the last 12 months, indemnities for participation into clinical study exceeding the annual threshold of 6000€ (including participation to this study).
研究组 & 干预措施
Healthy volunteer collecting stool samples
Experimental
Healthy volunteer collecting and bringing their stool samples to the investigational site.
干预措施: Standardized stool collection from healthy volunteers (Other)
结局指标
主要结局
Collect enough acceptable stool samples
时间窗: After 14 days of refrain period
次要结局
未报告次要终点
研究者
研究点 (1)
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