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Not yet recruiting NCT07687511

Oral Microbiota and Muscle Function in the Ageing Subject

No phase Interventional Non-hospitalised Men and Women Over 70 Years of Age

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Salivary and fecal microbiota sampling and muscle strength assessment.
Who it may be relevant to
Registry conditions: Non-hospitalised Men and Women Over 70 Years of Age. Basic parameters: from 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Oral Microbiota and Muscle Function in the Ageing Subject: MYOBIOTA Study

Overview

Ageing of the general population may be a risk factor for various complications, including sarcopenia. Sarcopenia is a progressive loss of muscle mass and muscle strength, leading to a decrease in functional capacities. It affects between 0.7% and 16% of European adults over 70 years of age (1). Recent studies suggest that the faecal microbiota may be altered with ageing but also according to sarcopenic status. Furthermore, no study has currently published data on the relationship between salivary microbiota and sarcopenic status. The main hypothesis of this study is that a decrease in salivary microbiota richness could be associated with impaired handgrip strength in the ageing subject.

Interventions

  • Procedure Salivary and fecal microbiota sampling and muscle strength assessment
    Collection of saliva and stool samples for microbiota analysis and assessment of handgrip strength in adults aged over 70 years.

Primary outcome measures

  • Salivary microbiota richness [Time frame: baseline]
Secondary outcome measures (6)
  • Fecal microbiota diversity [Time frame: 15 days]
  • Title: Fecal microbiota richness [Time frame: 15 days]
  • Salivary microbiota diversity [Time frame: 15 days]
  • Fecal microbiota richness according to sarcopenia status [Time frame: 15 days]
  • handgrip strength [Time frame: 15 days]
  • Risk factors associated with low microbiota genomic diversity [Time frame: 15 days]

Eligibility criteria

Inclusion criteria

  • Male or female adult volunteer, over 70 years of age
  • Non-hospitalised
  • Having read and understood the information letter and signed the consent form
  • Affiliated with a Social Security scheme

Exclusion criteria

  • Already included in an interventional drug clinical trial
  • Unable to understand and complete the questionnaires
  • Deprived of liberty by an administrative or judicial decision or protected adult subject (under guardianship, curatorship or judicial protection order)
  • Receiving antibiotic treatment or having received antibiotic treatment during the previous 3 months
  • Taking or having taken probiotics during the previous 3 months
  • Having undergone colonic lavage/bowel cleansing during the previous 3 months
  • Presenting one of the following situations likely to alter the microbiota: active cancer, eating disorders, exclusive vegetarian diet, history of digestive surgery
  • Having a cardiac pacemaker
  • Living in a nursing home for dependent elderly persons (EHPAD)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • Rouen University Hospital — Rouen

Identifiers

NCT: NCT07687511 · 2024/0100/HP · 2025-A02657-42

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗