CHU
Clermont-Ferrand, 63000, France
NCT Number: NCT04753580
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.
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Notify Me18 year–90 year
Male
Interventional
Not applicable
Clermont-Ferrand, 63000, France
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 :
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Healthy adult group and Healthy elderly group:
Fragile elderly group:
Same non-inclusion criteria as above except modification on 2 criteria:
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.
Time frame: Day +7
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 0
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
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
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
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
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
The percentage of fat mass (%) (body composition) will be determined on each participant using a multi-frequency bioelectrical Impedance Analyzer.
Time frame: Day 0
The percentage of lean mass (%) (body composition) will be determined on each participant using a multi-frequency bioelectrical Impedance Analyzer.
Time frame: Day 0
The percentage of water (%) (body composition) will be determined using a multi-frequency bioelectrical Impedance Analyzer.
Time frame: Day -7
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
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
Determination of glucose plasma concentration (mmol/L) (a metabolic parameter).
Time frame: Day -7
Determination of creatinine plasma concentration (µmol/L) (a metabolic parameter).
Time frame: Day -7
Determination of the creatinine clearance (ml/min) (a metabolic parameter).
Time frame: Day -7
Description: Determination of albumin plasma concentration (a metabolic parameter).
Time frame: Day -7
Determination of total cholesterol plasma concentration (mmol/L) (a metabolic parameter).
Time frame: Day -7
Description: Determination of HDL-chol plasma concentration (mmol/L) (a metabolic parameter).
Time frame: Day -7
Determination of triglycerides concentration (mmol/L) (a metabolic parameter).
Time frame: Day -7
Determination of liver enzymes concentration (U/L) (a metabolic parameter).
Time frame: Day -7
Determination phosphatase alkaline concentration (U/100mL) (a metabolic parameter).
Time frame: Day -7
Determination C-reactive protein concentration (a metabolic parameter).
Time frame: Day -7
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
Determination of TNF-alpha plasma concentration (pg/ml)
Time frame: Day -7
Determination of IL-1 plasma concentration (pg/ml)
Time frame: Day -7
Determination of IL-6 plasma concentration (pg/ml)
Time frame: Day -7
Determination of MCP1 plasma concentration (pg/ml)
Time frame: Day -7
Determination of IL10 plasma concentration (pg/ml)
Time frame: Day -7
Determination of LPS-binding protein plasma concentration (ng/ml)
Time frame: Day -7
Determination of sDC14 plasma concentration (ng/ml)
University Hospital, Clermont-Ferrand
Other
Acronym: FRAGIBIOTE
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View the official ClinicalTrials.gov record (opens in a new tab)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.
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