Rouen University Hospital
Rouen, France
Not Yet Recruiting
NCT Number: NCT07687511
Oral Microbiota and Muscle Function in the Ageing Subject
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Age range
70 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
Salivary and fecal microbiota sampling and muscle strength assessment
ProcedureCollection of saliva and stool samples for microbiota analysis and assessment of handgrip strength in adults aged over 70 years.
Primary outcomes
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Salivary microbiota richness
Time frame: baseline
Salivary microbiota richness (gene richness/alpha diversity) measured from saliva samples.
Secondary outcomes
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Fecal microbiota diversity
Time frame: 15 days
Assessment of fecal microbiota diversity from stool samples and its association with maximal handgrip strength.
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Title: Fecal microbiota richness
Time frame: 15 days
Assessment of fecal microbiota richness according to handgrip strength and sarcopenia status.
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Salivary microbiota diversity
Time frame: 15 days
Assessment of salivary microbiota diversity from saliva samples and its association with maximal handgrip strength.
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Fecal microbiota richness according to sarcopenia status
Time frame: 15 days
Comparison of fecal microbiota richness between participants with and without sarcopenia.
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handgrip strength
Time frame: 15 days
Identification of microbiological and clinical factors associated with lower maximal handgrip strength.
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Risk factors associated with low microbiota genomic diversity
Time frame: 15 days
Identification of factors associated with reduced microbial gene richness and diversity in saliva and stool samples.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University Hospital, Rouen
Other
Registry information
Official study title
Oral Microbiota and Muscle Function in the Ageing Subject: MYOBIOTA Study
Acronym: MYOBIOTA
Important dates
- Study start
- 2026
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Jul 7, 2026
- Registry last updated
- Jul 7, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.