跳至主要内容
临床试验/NCT05449119
NCT05449119招募中不适用

Loss of Autonomy in the Elderly: Relationships Between Gut Microbiota Diversity, Nutrition and Cognitive and Sensory-motor Disturbances in "Small Eaters" and "Non Small Eaters"

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2023年6月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
140
试验地点
1
主要终点
Measurement of the beta diversity of the microbiota and the intestinal mycobiota

研究概览

简要总结

Older adults currently make up 25% of the population in France, and future health expenditures will be largely related to the consequences of aging. Normal aging is associated with a progressive decrease in cognitive and sensorimotor function, malnutrition and/or under-nutrition and intestinal dysbiosis (i.e. changes in the composition and/or stability of the microbiota). Furthermore, admission to long-term care facilities such as Etablissement d'Hébergement pour Personnes Agées Dépendantes (EHPAD) leads to drastic changes in lifestyle in terms of (i) nutrition and (ii) motor functions. These modifications can influence the composition of the intestinal microbiota and its temporal evolution.

We will study the relationship between the deterioration of cognitive and sensorimotor function, diet and intestinal well-being (i.e. microbiota) of a cohort of older adults (>75 years) defined as "small eaters" from their admission in EHPAD at the University Hospital of Dijon. This study will be carried out by a unique French multidisciplinary consortium that includes academics and health professionals, who will be able to specify the criteria defining the "small eaters" and to envisage suitable dietary strategies aiming to preserve their nutritional status and intestinal well-being. The final goal is to improve quality of life at home by prolonging autonomy and independence, and thus to deferring admission to an EHPAD for as long as possible.

The objective of this study is to build a cohort of elderly "small eaters" and a cohort of elderly "non small eaters". These patients will be followed over a period of one year. The evolution of the composition of the intestinal microbiota will be determined in order to establish the existing relations between the composition of digestive microbiota, the nutritional state, and cognitive and sensorimotor function.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Person who has given oral consent and has not objected to being included in the study, or if necessary, oral consent of an appointed legal representative.
  • A person over 75 years of age residing in an EHPAD who may be under guardianship or curatorship.
  • A person over 75 years of age with a loss of appetite (i.e. a small eater) residing in an EHPAD, who may be under guardianship or curatorship.

排除标准

  • Person not affiliated to national health insurance
  • Elderly person with an infectious syndrome at the time of admission;
  • Elderly person with diarrhoea (infectious or not) at the time of admission;
  • Elderly person receiving recently prescribed antimicrobials at the time of admission (antibiotics or antifungals)
  • Elderly person with celiac disease and/or Crohn's disease.
  • Person under a measure of limited judicial protection

结局指标

主要结局

Measurement of the beta diversity of the microbiota and the intestinal mycobiota

时间窗: up to T12 months

Measure of species diversity between samples

Measurement of the alpha diversity of the microbiota and the intestinal mycobiota

时间窗: up to T12 months

Measure indicating the diversity of a single sample

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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