Microbial ColonizationORAMICAPNCT05765422
The Influence of Endurance Sports Activity on the Oral Microbiota of Young Adults.
A study testing salivar and gum sampling in people with Microbial Colonization, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The oral cavity is an easily accessible anatomical site that accurately reflects the health of the individual. The mouth is considered an early indicator of biological aging, leading to the identification of oral biomarkers predictive of future alterations. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- salivar and gum sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteFrance
- Study dates
- 17 Oct 2022to 27 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be between 18 and 30 years old
- If practicing sports, it must be an endurance sport as main activity (cycling or running)
Who cannot join
- Practice more than 3 hours of swimming per week
- Have taken anti-inflammatory drugs, less than 48 hours before the study
- Have taken antibiotics and/or probiotics, less than 3 weeks before the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sport and Health a Pilot Study: Impact of Endurance Physical Activity on the Microbiological Homeostasis of the Oral Cavity of Young Adults
The oral cavity is an easily accessible anatomical site that accurately reflects the health of the individual. The mouth is considered an early indicator of biological aging, leading to the identification of oral biomarkers predictive of future alterations. Current data show that the oral health of high level athletes is globally altered with an increase in cariogenic indexes, an increased incidence of periodontitis, dental trauma and dry mouth syndromes. Few studies have focused on the oral microbiota compared to mouthguards used in rugby or boxing which seem to induce dysbiosis, a recent study shows an effect of ketogenic diet on bacterial changes in the mouth of endurance athletes. This project focuses on the impact of intensive sport practice on oral health and the identification of oral biomarkers associated with physical activity. The objective of this study is to investigate the impact of the amount of endurance sport practice on oral microbiota and oral health in young adults. the hypothesis is that a sedentary lifestyle and high-level sport induce depletion and/or changes in the oral microbiota compared to regular physical activity.
- Conditions
- Microbial Colonization
- Being tested
- salivar and gum sampling
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salivar and gum samplingOther
Saliva will then be collected by salivary spit and a mucosal smear will be taken using a swab passed at the junction of the tooth and the gum
| Study group | Role | What they receive |
|---|---|---|
| sedentary | Other | Participant does not meet WHO's recommendations with the physical activity Receives: Other: salivar and gum sampling |
| OMS recommandations | Other | Participant does not meet WHO's recommendations (2.5-5 hours per week of moderate physical activity OR 1.25-2.5 hours per week of vigorous physical activity); Receives: Other: salivar and gum sampling |
| More than the OMS recommandations | Other | Participant is practicing physical activity more than the WHO recommendations Receives: Other: salivar and gum sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the oral microbiota in healthy individuals engaged in endurance physical activity at different levels.
Microbiological screening will be performed using an innovative methodology based on microfluidic PCR (BiomarkHD) (number of bacterial colonies)
Measured: 3 years
Secondary outcomes (1)
Quantification of salivary inflammatory markers in healthy individuals who perform endurance physical activity at different levels.
numer and type of salivary inflammatory markers will performed using multiplex analysis technology developed by the firm Meso Scale Diagnostic (MSD).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start17 Oct 2022
- Primary completion27 Jan 2025
- Study completion27 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765422
- Sponsor's protocol ID
- 22-PP-11
- Other IDs
- 2022-A01682-41
- Acronym
- ORAMICAP
- Status last verified
- Jun 2025
- First submitted
- 1 Mar 2023
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ortis M, Dubois M, Bougault V, Legueult K, Fassy J, Mari B, Bertrand MF, Lupi L, Doglio A. ORASPORT study protocol: a prospective observational study on the impact of endurance physical activity on oral microbiology and immunology. Front Oral Health. 2025 Dec 5;6:1692359. doi: 10.3389/froh.2025.1692359. eCollection 2025.
PubMed 41424657
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sport and Health a Pilot Study: Impact of Endurance Physical Activity on the Microbiological Homeostasis of the Oral Cavity of Young Adults
- ClinicalTrials.gov ID
- NCT05765422
- Acronym / sponsor ID
- ORAMICAP / 22-PP-11
- Conditions
- Microbial Colonization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 27 Jan 2025 (actual)
- Study completion
- 27 Jan 2025 (actual)
- First posted
- 13 Mar 2023 (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.
The oral cavity is an easily accessible anatomical site that accurately reflects the health of the individual. The mouth is considered an early indicator of biological aging, leading to the identification of oral biomarkers predictive of future alterations. Current data show that the oral health of high level athletes is globally altered with an increase in cariogenic indexes, an increased incidence of periodontitis, dental trauma and dry mouth syndromes. Few studies have focused on the oral microbiota compared to mouthguards used in rugby or boxing which seem to induce dysbiosis, a recent study shows an effect of ketogenic diet on bacterial changes in the mouth of endurance athletes. This project focuses on the impact of intensive sport practice on oral health and the identification of oral biomarkers associated with physical activity. The objective of this study is to investigate the impact of the amount of endurance sport practice on oral microbiota and oral health in young adults. the hypothesis is that a sedentary lifestyle and high-level sport induce depletion and/or changes in the oral microbiota compared to regular physical activity.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sedentary | Other | Other: salivar and gum samplingParticipant does not meet WHO's recommendations with the physical activity |
| OMS recommandations | Other | Other: salivar and gum samplingParticipant does not meet WHO's recommendations (2.5-5 hours per week of moderate physical activity OR 1.25-2.5 hours per week of vigorous physical activity); |
| More than the OMS recommandations | Other | Other: salivar and gum samplingParticipant is practicing physical activity more than the WHO recommendations |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Be between 18 and 30 years old
- If practicing sports, it must be an endurance sport as main activity (cycling or running)
Key exclusion criteria (3 listed)
- Practice more than 3 hours of swimming per week
- Have taken anti-inflammatory drugs, less than 48 hours before the study
- Have taken antibiotics and/or probiotics, less than 3 weeks before the study
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 |
|---|---|---|
| salivar and gum samplingSaliva will then be collected by salivary spit and a mucosal smear will be taken using a swab passed at the junction of the tooth and the gum | Other | More than the OMS recommandations, OMS recommandations, sedentary |
Primary outcome
Analysis of the oral microbiota in healthy individuals engaged in endurance physical activity at different levels.
Time frame: 3 years
Microbiological screening will be performed using an innovative methodology based on microfluidic PCR (BiomarkHD) (number of bacterial colonies)
1 secondary outcome
Quantification of salivary inflammatory markers in healthy individuals who perform endurance physical activity at different levels.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Derived from this study: PubMed 41424657Ortis M, Dubois M, Bougault V, Legueult K, Fassy J, Mari B, Bertrand MF, Lupi L, Doglio A. ORASPORT study protocol: a prospective observational study on the impact of endurance physical activity on oral microbiology and immunology. Front Oral Health. 2025 Dec 5;6:1692359. doi: 10.3389/froh.2025.1692359. eCollection 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing salivar and gum sampling in people with Microbial Colonization, run by Centre Hospitalier Universitaire de Nice 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 30 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the oral microbiota in healthy individuals engaged in endurance physical activity at different levels. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05765422, which also lists 1 linked publication.
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 30 Jun 2026.