Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Frail Volunteers
  • Healthy Volunteers
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 90 years
Gender
Only males

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...

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 0 - 7 (visit 2). 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 protocole includes 3 visits : Visit 1 : Day 0-7 = inclusion Visit 2 : Day 0 = tests and questionnaires Visit 3 : Day 0 ± 7 : stool collect

Tracking Information

NCT #
NCT04753580
Collaborators
  • Unite de Nutrition Humaine UMR 1019- INRAE
  • Unite MetaGenoPolis INRAE
  • France MICALIS Equipe ProbiHote UMR INRAE
Investigators
Principal Investigator: Gisèle PICKERING University Hospital, Clermont-Ferrand