Non-hospitalised Men and Women Over 70 Years of AgeMYOBIOTANCT07687511
Oral Microbiota and Muscle Function in the Ageing Subject
A study testing Salivary and fecal microbiota sampling and muscle strength assessment in people with Non-hospitalised Men and Women Over 70 Years of Age, run by University Hospital, Rouen at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-hospitalised Men and Women Over 70 Years of Age
- What is being tested?
- Salivary and fecal microbiota sampling and muscle strength assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
HERVET contact
About this study
Official title: 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.
- Being tested
- Salivary and fecal microbiota sampling and muscle strength assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary and fecal microbiota sampling and muscle strength assessmentProcedure or surgery
Collection of saliva and stool samples for microbiota analysis and assessment of handgrip strength in adults aged over 70 years.
| Study group | Role | What they receive |
|---|---|---|
| Study Participants | Experimental | Collection of saliva and stool samples for microbiota analysis and assessment of handgrip strength in adults aged over 70 years. Receives: Procedure: Salivary and fecal microbiota sampling and muscle strength assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary microbiota richness
Salivary microbiota richness (gene richness/alpha diversity) measured from saliva samples.
Measured: baseline
Secondary outcomes (6)
Fecal microbiota diversity
Assessment of fecal microbiota diversity from stool samples and its association with maximal handgrip strength.
Measured: 15 days
Title: Fecal microbiota richness
Assessment of fecal microbiota richness according to handgrip strength and sarcopenia status.
Measured: 15 days
Salivary microbiota diversity
Assessment of salivary microbiota diversity from saliva samples and its association with maximal handgrip strength.
Measured: 15 days
Fecal microbiota richness according to sarcopenia status
Comparison of fecal microbiota richness between participants with and without sarcopenia.
Measured: 15 days
handgrip strength
Identification of microbiological and clinical factors associated with lower maximal handgrip strength.
Measured: 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.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-hospitalised Men and Women Over 70 Years of AgeStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687511
- Sponsor's protocol ID
- 2024/0100/HP
- Other IDs
- 2025-A02657-42
- Acronym
- MYOBIOTA
- Status last verified
- Jul 2026
- First submitted
- 19 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Microbiota and Muscle Function in the Ageing Subject: MYOBIOTA Study
- ClinicalTrials.gov ID
- NCT07687511
- Acronym / sponsor ID
- MYOBIOTA / 2024/0100/HP
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Participants | Experimental | Procedure: Salivary and fecal microbiota sampling and muscle strength assessmentCollection of saliva and stool samples for microbiota analysis and assessment of handgrip strength in adults aged over 70 years. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salivary and fecal microbiota sampling and muscle strength assessmentCollection of saliva and stool samples for microbiota analysis and assessment of handgrip strength in adults aged over 70 years. | Procedure or surgery | Study Participants |
Primary outcome
Salivary microbiota richness
Time frame: baseline
Salivary microbiota richness (gene richness/alpha diversity) measured from saliva samples.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
HERVET contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salivary and fecal microbiota sampling and muscle strength assessment in people with Non-hospitalised Men and Women Over 70 Years of Age, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. DECHELOTTE (+33 2 32 88 56 70, pierre.dechelotte@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary microbiota richness (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.