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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04753580
Study type Interventional
Source University Hospital, Clermont-Ferrand
Contact
Status Completed
Phase N/A
Start date October 4, 2021
Completion date September 14, 2022

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