- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05765422
The Influence of Endurance Sports Activity on the Oral Microbiota of Young Adults. (ORAMICAP)
March 1, 2023 updated by: Centre Hospitalier Universitaire de Nice
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Margaux DUBOIS, PH
- Phone Number: 0489152267
- Email: Margaux.DUBOIS@univ-cotedazur.fr
Study Contact Backup
- Name: Morgane Ortis, PH
- Phone Number: 0489152267
- Email: Morgane.ORTIS@univ-cotedazur.fr
Study Locations
-
-
-
Nice, France, 06000
- Nice University Hospital
-
Contact:
- Margaux Dubois
- Phone Number: 04.89.15.22.67
- Email: Margaux.DUBOIS@univ-cotedazur.fr
-
Contact:
- Morgane Ortis
- Phone Number: 0489152267
- Email: Morgane.ORTIS@univ-cotedazur.fr
-
Principal Investigator:
- Margaux Dubois
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Be between 18 and 30 years old
- If practicing sports, it must be an endurance sport as main activity (cycling or running)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: sedentary
Participant does not meet WHO's recommendations with the physical activity
|
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
|
Other: OMS recommandations
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);
|
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
|
Other: More than the OMS recommandations
Participant is practicing physical activity more than the WHO recommendations
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantification of salivary inflammatory markers in healthy individuals who perform endurance physical activity at different levels.
Time Frame: 3 years
|
numer and type of salivary inflammatory markers will performed using multiplex analysis technology developed by the firm Meso Scale Diagnostic (MSD).
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 15, 2023
Primary Completion (Anticipated)
March 15, 2026
Study Completion (Anticipated)
March 15, 2026
Study Registration Dates
First Submitted
March 1, 2023
First Submitted That Met QC Criteria
March 1, 2023
First Posted (Actual)
March 13, 2023
Study Record Updates
Last Update Posted (Actual)
March 13, 2023
Last Update Submitted That Met QC Criteria
March 1, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-PP-11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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