Vaginal MicrobiotaVAGINOTYPENCT06486519
Collection of Vaginal Microbiota Samples (VAGINOTYPE)
An observational study of Vaginal Microbiota, run by Lallemand Health Solutions at 2 sites in France.
Trial summary
The aim of this study is to collect vaginal microbiota samples from healthy women who are subject to vaginal and urinary infections. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Microbiota
- How many people
- 200 participants
- Where
- 2 sitesFrance
- Study dates
- 14 May 2024to 11 Sep 2024
- Phase
- Observational
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy females from 18 to 60 years of age inclusively that are willing to participate in the study and to provide a vaginal swab sample. Females that are subject to vaginal or urinary infections.
Who may be able to join
- I1. Age between 18 and 60 years (limits included),
- I2. BMI between 18 and 30 kg/m² (limits included),
- I3. Good general and mental health within the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination,
- I4. Able and willing to participate to the study by complying with the protocol procedures as evidenced by the dated and signed informed consent form,
- I5. Affiliated with a social security scheme,
- I6. Women who have had a vaginal or urinary infection in the last two years.
Who cannot join
- E1. Suffering from gastrointestinal acute or chronic disease or complication (e.g. celiac disease, gastroesophageal reflux disease, gastric or duodenal ulcer, Crohn's disease, hemorrhoids, irritable bowel syndrome) or frequent gastrointestinal disorders (e.g. diarrhea, nausea, vomiting, abdominal pain, constipation, hemorrhoids...)
- E2. Any infectious gastrointestinal complaint within 4 weeks before V1
- E3. Suffering from a metabolic disorder such as diabetes, thyroidal trouble, arterial hypertension or other metabolic disorder or any disease requiring a chronic treatment
- E4. Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, cardiac, hepatic or biliary disorders ongoing, chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble, etc.) or disease found to be inconsistent with the conduct of the study by the investigator
- E5. Suffering from a pathology of the oral sphere (untreated caries, gingivitis, periodontitis, abscess, etc.) or having a positive result in an oral swab test for STIs (chlamydia, gonococcus, syphilis, herpes, etc.)
- E6. Women affected by a Sexually Transmitted Infection (STI) or Disease (STD) such as HPV (Human PapillomaVirus), Chlamydia infection, syphilis, gonorrhea, genital herpes
Show all 16Show fewer
- E7. Having undergone a surgical procedure likely to disrupt the gut microbiome within the 6 months prior to the V1 visit, especially bariatric surgery
- E8. Coloscopy within 3 months prior to the visit
- E9. Women who gave birth within one year of the visit, women who are pregnant or intend to become pregnant during the study, women who are breastfeeding
- E10.Previous or current antibiotic, antiviral, antifungal, proton pump inhibitor, or any treatment which may disrupt the microbiota in the 4 weeks prior to the V1 visit
- E11.In the process of quitting smoking or having started smoking less than 6 months ago
- E12.Taking part in another clinical trial or being in the exclusion period of a previous clinical trial
- E13. Having received, during the last 12 months, indemnities for clinical trial higher or equal to 6000 Euros
- E14.Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision
- E15.Presenting a psychological or linguistic incapability to sign the informed consent
- E16.Impossible to contact in case of emergency
Trial locations and contacts
2 sites in 1 country.
France2 sites
Biofortis, Unité d'Investigation Clinique
Paris, 75012
Biofortis, Unité d'Investigation Clinique
Saint-Herblain, 44800
About this study
Official title: Collection of Vaginal Microbiota from Healthy Women Subject to Vaginal and Urinary Infections (VAGINOTYPE)
The aim of this study is to collect vaginal microbiota samples from healthy women who are subject to vaginal and urinary infections.
Read the detailed description
The goal of this study is to collect vaginal swab samples in order to gain knowledge on vaginal microbial communities of healthy women who have had experiences with vaginal and urinary infections.
Eligible participants will be enrolled in the study for a total duration of 1 day, where they will provide consent, answer a questionnaire and collect the vaginal samples.
- Conditions
- Vaginal Microbiota
- Keywords
- VAGINOTYPE, Urinary tract infections, Vaginal infections, Women's health
- Medical subject headings
- Urinary Tract Infections, Vaginitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Composition of the vaginal microbiome
Vaginal microbiota composition (α-diversity, β-diversity, and relative abundance at the genus and species level) at a single point in time via shotgun sequencing.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start14 May 2024
- Primary completion11 Sep 2024
- Study completion11 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal MicrobiotaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lallemand Health Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Responsible party
- Sponsor
- Investigators
- Isabelle Metreau, MD, Principal investigator, Biofortis, Unité d'Investigation Clinique de Saint-Herblain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486519
- Sponsor's protocol ID
- L-031
- Other IDs
- 2022-A01997-36
- Acronym
- VAGINOTYPE
- Status last verified
- Sep 2024
- First submitted
- 27 Jun 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Vaginal Microbiota from Healthy Women Subject to Vaginal and Urinary Infections (VAGINOTYPE)
- ClinicalTrials.gov ID
- NCT06486519
- Acronym / sponsor ID
- VAGINOTYPE / L-031
- Conditions
- Vaginal Microbiota
- Keywords
- VAGINOTYPE, Urinary tract infections, Vaginal infections, Women's health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Lallemand Health SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Study start
- 14 May 2024 (actual)
- Primary completion
- 11 Sep 2024 (actual)
- Study completion
- 11 Sep 2024 (actual)
- First posted
- 3 Jul 2024 (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 aim of this study is to collect vaginal microbiota samples from healthy women who are subject to vaginal and urinary infections.
Detailed description
The goal of this study is to collect vaginal swab samples in order to gain knowledge on vaginal microbial communities of healthy women who have had experiences with vaginal and urinary infections.
Eligible participants will be enrolled in the study for a total duration of 1 day, where they will provide consent, answer a questionnaire and collect the vaginal samples.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy females from 18 to 60 years of age inclusively that are willing to participate in the study and to provide a vaginal swab sample. Females that are subject to vaginal or urinary infections.
Key inclusion criteria (6 listed)
- I1. Age between 18 and 60 years (limits included),
- I2. BMI between 18 and 30 kg/m² (limits included),
- I3. Good general and mental health within the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination,
- I4. Able and willing to participate to the study by complying with the protocol procedures as evidenced by the dated and signed informed consent form,
- I5. Affiliated with a social security scheme,
Key exclusion criteria (16 listed)
- E1. Suffering from gastrointestinal acute or chronic disease or complication (e.g. celiac disease, gastroesophageal reflux disease, gastric or duodenal ulcer, Crohn's disease, hemorrhoids, irritable bowel syndrome) or frequent gastrointestinal disorders (e.g. diarrhea, nausea, vomiting, abdominal pain, constipation, hemorrhoids...)
- E2. Any infectious gastrointestinal complaint within 4 weeks before V1
- E3. Suffering from a metabolic disorder such as diabetes, thyroidal trouble, arterial hypertension or other metabolic disorder or any disease requiring a chronic treatment
- E4. Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, cardiac, hepatic or biliary disorders ongoing, chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble, etc.) or disease found to be inconsistent with the conduct of the study by the investigator
- E5. Suffering from a pathology of the oral sphere (untreated caries, gingivitis, periodontitis, abscess, etc.) or having a positive result in an oral swab test for STIs (chlamydia, gonococcus, syphilis, herpes, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composition of the vaginal microbiome
Time frame: 1 day
Vaginal microbiota composition (α-diversity, β-diversity, and relative abundance at the genus and species level) at a single point in time via shotgun sequencing.
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 19 Sep 2024.
- 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.
Isabelle Metreau, MD principal investigator
Biofortis, Unité d'Investigation Clinique de Saint-Herblain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Microbiota, run by Lallemand Health Solutions at 2 sites 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 6 inclusion and 16 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Composition of the vaginal microbiome (time frame: 1 day). 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 19 Sep 2024.