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NCT Number: NCT05449119

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"

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.

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Key information

Conditions

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourgogne

Dijon, 21000, France

Location status: Recruiting

Location contact

Frédéric DALLE

CONTACT

[email protected]

0380295014

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Fecal and blood sampling and collection of nutritional, cognitive and sensorimotor data

Biological

at T0, T3 months, T6 months, T9 months and T12 months

Body mass index (BMI)

Other

Calculation of BMI with height measurement by heel-knee distance measurement at T0, T3 months, T6 months, T9 months and T12 months

24-hour food and beverage record

Other

at T0, T3 months, T6 months, T9 months and T12 months

Mini Nutritional assessment (MNA)

Other

at T0, T3 months, T6 months, T9 months and T12 months

Measurement of muscle mass by bioelectrical impedance analysis (except for participants with a pacemaker)

Other

at T0, T3 months, T6 months, T9 months and T12 months

Measurement of sensorimotor functions

Other

at T0, T3 months, T6 months, T9 months and T12 months

Measurement of cognitive functions

Other

at T0, T3 months, T6 months, T9 months and T12 months

Primary outcomes

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

    Time frame: up to T12 months

    Measure indicating the diversity of a single sample

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

    Time frame: up to T12 months

    Measure of species diversity between samples

Study contacts

Contact information is provided by the study sponsor or research team.

Frédéric DALLE

CONTACT

[email protected]

0380295014

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: ALMICO

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jul 8, 2022
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.