NCT04753580

Sampling of Human Microbiota in Order to Test, on a Mouse Model, Individualized Intervention Strategies During Aging

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: Male
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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 : * Visit 1 : Day -7 (allowed until Day-14) = inclusion * Visit 2 : Day 0 = tests and questionnaires * Visit 3 : Day +7 (allowed from Day+1) = stool collect

Conditions

• Healthy Volunteers
• Frail Volunteers

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-04
• Primary completion: 2022-09-14
• Completion: 2022-09-14
• First posted: 2021-02-15
• Last updated: 2022-10-06

Locations

1 site across 1 country: France