An interventional study of Stool collection in Healthy Volunteers and Frail Volunteers, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to male participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-06.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Basic science
Human microbial flora transfer studies in rodent models have clearly identified that age-associated microbiota dysbiosis can play a decisive role with respect to pathologies or complications linked to aging: increased intestinal permeability, in place of systemic inflammation, dysfunction of immune cells and insulin resistance.
This trial therefore aims to validate the process of ex vivo transfer to the rat of human microbiota selected from three categories of male individuals: young adults, healthy older adults and frail older adults, with the evaluation of the bacterial population of stool by analysis of the 16S rRNA gene.
This is a pilot study to validate a process of ex vivo stool transfer from humans to rats. Single-center intervention research with minimal risks and constraints.
Exploration of the bacterial composition of the intestinal microbiota in healthy adult volunteers, healthy elderly and frail elderly. The evaluation of the bacterial population of the stool will be done by analysis of the 16S rRNA gene.
The secondary objectives will evaluate the muscular functional abilities the body composition measurement, at Day 0 (visit 2) and the inflammatory status at Day -7 (visit 1).
Seconds parameters are the following :
seated, standing, walking, and direction changes, a balance test, a walking speed test and a chair lift test, the maximum voluntary force of manual gripping, the maximum muscle strength of the quadriceps and the level of autonomy
This protocol includes 3 visits :
University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
Healthy adult group and Healthy elderly group:
Fragile elderly group:
Same non-inclusion criteria as above except modification on 2 criteria:
healthy adult 20-35 years old
Genetic: Stool collection
healthy elderly 65+ years old
Genetic: Stool collection
Frail elderly 65+ years old
Genetic: Stool collection
The volunteer will receive the stool collection kit as well as the procedure to follow for this collection. Treatment of stool after collection: The stool will be treated according to the following two procedures: i) part of the stool will be sequenced and will be stored as quickly as possible (4 hours maximum) at -80 ° C, 3 separate aliquots of 1 g; ii) the other part will be intended for implantation in rats and must be homogenized in a final concentration of 20% glycerol (2 hours maximum) and then stored at -80 ° C, 3 aliquots of 1 g.
Evaluation of the bacterial population of the stool by analysis of the 16S rRNA gene
Random metagenomic sequencing. The DNA sequences obtained will be aligned with catalogs of genes and microbial species representative of the gut microbiota to obtain a detailed microbial and functional profile (catalog of 10.4 million genes and \~ 2000 intestinal microbial species)
Time frame: Day +7
Measurement of muscular functional aptitudes with the Get up and Go muscular test scale
Test that assesses seated, standing, walking and changes of direction transfers. This is a simple validated field test modified secondarily by adding the measured time. The subject is seated on a chair with armrests, placed in front of a wall 3 meters away. The subject should stand up, remain standing, walk to the wall, turn around without touching the wall, return to the seat, walk around it and sit down again. The rating is carried out with a scale rated from 1 to 5: 1 - no instability ; 2 - very slightly abnormal (slow execution) ; 3 - moderately abnormal (hesitation, compensatory movements) ; 4 - abnormal (the patient trips) ; 5 - very abnormal (permanent risk of falling).
Time frame: Day 0
Measurement of muscular functional aptitudes with the Short Physical Performance Battery (SPPB) score
This test includes a balance test, a walking speed test and a chair lift test. It makes it possible to assess the physical performance of an individual. Adding up the scores for all tests provides an overall performance score. A score of less than 8 is an indicator of the risk of sarcopenia (or age-related muscular dystrophy)
Time frame: Day 0
Evaluation of the the maximum voluntary force of manual gripping.
Measurement (in Newton) carried out on the dominant limb in a seated position, elbow resting on a table, with a Jamard dynamometer. The subject must make a gripping movement as hard as possible. Three reproducible measurements (+/- 10%) will be taken at 1 minute intervals and the highest value will be retained.
Time frame: Day 0
Evaluation of the voluntary level of autonomy with Functional Independence Measure (FIM) questionnaire
This test includes 18 items that assess a person's level of autonomy in their daily activities. Motor skills are measured by 13 tasks which are grouped under 4 categories of activities: Cognitive abilities are measured by 5 tasks which are grouped under 2 categories of activities:
Time frame: Day 0
Measurement of the distance travelled in 6 minutes with the 6-minute walk test
6-minute walk test performed according to ATS recommendations. Measurement of the distance travelled in 6 minutes in a lane of 30 meters by the subject with collection of basic parameters (heart rate).
Time frame: Day 0
Fat mass ratio determination
The percentage of fat mass (%) (body composition) will be determined on each participant using a multi-frequency bioelectrical Impedance Analyzer.
Time frame: Day 0
Lean mass ratio determination
The percentage of lean mass (%) (body composition) will be determined on each participant using a multi-frequency bioelectrical Impedance Analyzer.
Time frame: Day 0
Water mass ratio determination
The percentage of water (%) (body composition) will be determined using a multi-frequency bioelectrical Impedance Analyzer.
Time frame: Day 0
Evaluation of the participant nutritional state with Mini Nutritional Assessment (MNA)
The Mini Nutritional Assessment is structured in 18 questions grouped in four rubrics (anthropometry, general status, dietary habits, and self-perceived health and nutrition states). It allows grading the nutritional status according to defined thresholds: scores above 24 = good status; scores 23.5-17 = risk of malnutrition; scores below 17 = malnutrition.
Time frame: Day -7
Evaluation of the participant cognitive state with Mini Mental State Examination (MMSE)
The Mini Mental State Examination is structured in 30 questions grouped in six rubrics (orientation, registration, attention and calculation, memory, language, and copying). It allows the screening of cognitive impairments.
Time frame: Day -7
Plasma glucose dosage
Determination of glucose plasma concentration (mmol/L) (a metabolic parameter).
Time frame: Day -7
Plasma creatinine dosage
Determination of creatinine plasma concentration (µmol/L) (a metabolic parameter).
Time frame: Day -7
Creatinine clearance
Determination of the creatinine clearance (ml/min) (a metabolic parameter).
Time frame: Day -7
Plasma albumin dosage
Description: Determination of albumin plasma concentration (a metabolic parameter).
Time frame: Day -7
Plasma total cholesterol dosage
Determination of total cholesterol plasma concentration (mmol/L) (a metabolic parameter).
Time frame: Day -7
Plasma High Density Lipoprotein cholesterol (HDL-chol) dosage
Description: Determination of HDL-chol plasma concentration (mmol/L) (a metabolic parameter).
Time frame: Day -7
Plasma triglycerides dosage
Determination of triglycerides concentration (mmol/L) (a metabolic parameter).
Time frame: Day -7
Plasma liver enzymes (AST/ALT/GGT) dosage
Determination of liver enzymes concentration (U/L) (a metabolic parameter).
Time frame: Day -7
Plasma phosphatase alkaline dosage
Determination phosphatase alkaline concentration (U/100mL) (a metabolic parameter).
Time frame: Day -7
Plasma C-reactive protein dosage
Determination C-reactive protein concentration (a metabolic parameter).
Time frame: Day -7
Complete blood count (CBC)
Determination of the number of erythrocytes (millions/mm3), leukocytes (mm3/1000), platelets (mm3/1000), the hematocrit rate (%), the hemoglobin rate (g/100ml), the mean corpuscular hemoglobin (pg), mean corpuscular volume (µ3), mean corpuscular hemoglobin concentration (%)
Time frame: Day -7
Dosage of TNF-alpha allowing assessment of inflammatory status
Determination of TNF-alpha plasma concentration (pg/ml)
Time frame: Day -7
Dosage of IL1 allowing assessment of inflammatory status
Determination of IL-1 plasma concentration (pg/ml)
Time frame: Day -7
Dosage of IL6 allowing assessment of inflammatory status
Determination of IL-6 plasma concentration (pg/ml)
Time frame: Day -7
Dosage of MCP1 allowing assessment of inflammatory status
Determination of MCP1 plasma concentration (pg/ml)
Time frame: Day -7
Dosage of IL10 allowing assessment of inflammatory status
Determination of IL10 plasma concentration (pg/ml)
Time frame: Day -7
Dosage of LPS-binding protein allowing assessment of inflammatory status
Determination of LPS-binding protein plasma concentration (ng/ml)
Time frame: Day -7
Dosage of sDC14 allowing assessment of inflammatory status
Determination of sDC14 plasma concentration (ng/ml)
Time frame: Day -7
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University Hospital, Clermont-Ferrand