Oral Microbiota and Muscle Function in the Ageing Subject: MYOBIOTA Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Salivary microbiota richness
研究概览
简要总结
Ageing of the general population may be a risk factor for various complications, including sarcopenia. Sarcopenia is a progressive loss of muscle mass and muscle strength, leading to a decrease in functional capacities. It affects between 0.7% and 16% of European adults over 70 years of age (1). Recent studies suggest that the faecal microbiota may be altered with ageing but also according to sarcopenic status. Furthermore, no study has currently published data on the relationship between salivary microbiota and sarcopenic status. The main hypothesis of this study is that a decrease in salivary microbiota richness could be associated with impaired handgrip strength in the ageing subject.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female adult volunteer, over 70 years of age
- •Non-hospitalised
- •Having read and understood the information letter and signed the consent form
- •Affiliated with a Social Security scheme
排除标准
- •Already included in an interventional drug clinical trial
- •Unable to understand and complete the questionnaires
- •Deprived of liberty by an administrative or judicial decision or protected adult subject (under guardianship, curatorship or judicial protection order)
- •Receiving antibiotic treatment or having received antibiotic treatment during the previous 3 months
- •Taking or having taken probiotics during the previous 3 months
- •Having undergone colonic lavage/bowel cleansing during the previous 3 months
- •Presenting one of the following situations likely to alter the microbiota: active cancer, eating disorders, exclusive vegetarian diet, history of digestive surgery
- •Having a cardiac pacemaker
- •Living in a nursing home for dependent elderly persons (EHPAD)
结局指标
主要结局
Salivary microbiota richness
时间窗: baseline
Salivary microbiota richness (gene richness/alpha diversity) measured from saliva samples.
次要结局
- Fecal microbiota diversity(15 days)
- Title: Fecal microbiota richness(15 days)
- Salivary microbiota diversity(15 days)
- Fecal microbiota richness according to sarcopenia status(15 days)
- handgrip strength(15 days)
- Risk factors associated with low microbiota genomic diversity(15 days)
