Collection of Vaginal Microbiota Samples (VAGINOTYPE)

Collection of Vaginal Microbiota from Healthy Women Subject to Vaginal and Urinary Infections (VAGINOTYPE)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06486519

Acronym

VAGINOTYPE

Enrollment

200

Registered

2024-07-03

Start date

2024-05-14

Completion date

2024-09-11

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Microbiota

Keywords

VAGINOTYPE, Urinary tract infections, Vaginal infections, Women's health

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

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.

Exclusion criteria

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 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

Design outcomes

Primary

Measure	Time frame	Description
Composition of the vaginal microbiome	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.

Countries

France

Outcome results