Oral Microbiota and Muscle Function in the Ageing Subject (MYOBIOTA)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-hospitalised Men and Women Over 70 Years of Age
• Intervention / Treatment: Procedure: Salivary and fecal microbiota sampling and muscle strength assessment

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Prof. DECHELOTTE; Phone Number: +33 2 32 88 56 70; Email: pierre.dechelotte@chu-rouen.fr
• Study Contact Backup: Name: HERVET; Email: mylene.hervet@chu-rouen.fr

Study Locations

• France
  • Rouen, France
    • Rouen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Participants; Collection of saliva and stool samples for microbiota analysis and assessment of handgrip strength in adults aged over 70 years.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary microbiota richness	Salivary microbiota richness (gene richness/alpha diversity) measured from saliva samples.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal microbiota diversity	Assessment of fecal microbiota diversity from stool samples and its association with maximal handgrip strength.	15 days
Title: Fecal microbiota richness	Assessment of fecal microbiota richness according to handgrip strength and sarcopenia status.	15 days
Salivary microbiota diversity	Assessment of salivary microbiota diversity from saliva samples and its association with maximal handgrip strength.	15 days
Fecal microbiota richness according to sarcopenia status	Comparison of fecal microbiota richness between participants with and without sarcopenia.	15 days
handgrip strength	Identification of microbiological and clinical factors associated with lower maximal handgrip strength.	15 days
Risk factors associated with low microbiota genomic diversity	Identification of factors associated with reduced microbial gene richness and diversity in saliva and stool samples.	15 days

Collaborators and Investigators

• Sponsor: University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: June 19, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2024/0100/HP; 2025-A02657-42 (Registry Identifier: RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No