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

NCT04753580 | Completed

• 2 other identifiers: RBHP 2020 PICKERING 32020-A02978-31
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers; Frail Volunteers

Keywords

Genetic; Elderly; Microbiota

Outcome Measures

Primary Outcomes (1)

• 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)

  Day +7

Secondary Outcomes (28)

• Measurement of muscular functional aptitudes with the Get up and Go muscular test scale

  Day 0

• Measurement of muscular functional aptitudes with the Short Physical Performance Battery (SPPB) score

  Day 0

• Evaluation of the the maximum voluntary force of manual gripping.

  Day 0

• Evaluation of the voluntary level of autonomy with Functional Independence Measure (FIM) questionnaire

  Day 0

• Measurement of the distance travelled in 6 minutes with the 6-minute walk test

  Day 0

Study Arms (3)

group 1

EXPERIMENTAL

healthy adult 20-35 years old

Genetic: Stool collection

group 2

EXPERIMENTAL

healthy elderly 65+ years old

Genetic: Stool collection

group 3

EXPERIMENTAL

Frail elderly 65+ years old

Genetic: Stool collection

Interventions

Stool collection GENETIC

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.

group 1; group 2; group 3

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteer over the age 18,
• More than 50 kg and having a Body Mass Index (BMI) between 18 and 30 kg / m2 (inclusive),
• Subject aged between 20 and 35 years inclusive ("healthy adult" group, or 65 years (inclusive) and over ("healthy elderly" and "frail elderly" groups),
• Score of the Short Emergency Geriatric Assesment grid (SEGA - A) strictly less than 8 (see appendix 1) ("healthy adult" and "healthy elderly" groups), or greater than or equal to 8 ("frail elderly" group),
• Subject capable of giving informed consent to participate in the research,
• Subject having an affiliation to the French Social Security system.

You may not qualify if:

• Healthy adult group and Healthy elderly group:
• Subject presenting an acute pathology (unstable pathology), a life expectancy of \<3 months or major neuro-cognitive disorders,
• treated with antibiotic therapy 3 months before the start of the protocol,
• in the impossibility of carrying out the planned functionality tests,
• carrier of Pacemaker or implantable defibrillator,
• with renal insufficiency (clearance \<50 ml / min according to the CKD-EPI formula),
• presenting an untreated metabolic syndrome (presenting 3 of the 5 following criteria: waist circumference greater than 94 cm, blood triglyceride level greater than 1.7 mmol / l, blood pressure greater than or equal to 130 mm Hg / 85 mm Hg, cholesterol level (HDL) less than 1.0 mmol / l, fasting blood glucose greater than or equal to 5.6 mmol / l),
• suffering from diabetes (even treated),
• during a slimming diet,
• during treatment with chemotherapy,
• with gastrointestinal pathology,
• with intolerance (milk, lactose, gluten ...) or a diet other than omnivorous (vegetarians, vegans, vegans),
• smoking more than 4 cigarettes / day,
• drinking more than 2 glasses of alcohol per day,
• refusing not to smoke, vape or remove a nicotine patch the morning of the samples,

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Unite de Nutrition Humaine UMR 1019- INRAE: collaborator
• Unite MetaGenoPolis INRAE: collaborator
• France MICALIS Equipe ProbiHote UMR INRAE: collaborator

Study Sites (1)

CHU

Clermont-Ferrand, 63000, France

Location

Study Officials

• Gisèle PICKERING

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 15, 2021
• Study Start: October 4, 2021
• Primary Completion: September 14, 2022
• Study Completion: September 14, 2022
• Last Updated: October 6, 2022

Record last verified: 2022-07

Locations

FR (1)