Collection of Vaginal Microbiota Samples (VAGINOTYPE)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-14

Study Completion Date

2024-09-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to collect vaginal microbiota samples from healthy women who are subject to vaginal and urinary infections.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of the Composition and Bacterial Diversity of the Vaginal Microbiota in Healthy Versus Pathological Conditions (Bacterial Vaginosis) Using a Targeted Metagenomic Approach (RNA 16s)

NCT04989543

Vaginosis, Bacterial

COMPLETED NA

Research on Vaginal Microbiota Evaluation Unified Standards Based on Gram Staining

NCT05997160

Vaginal Infection

UNKNOWN

Examining the Impact of Tampon Use on the Vaginal Microbiota

NCT03346759

Vaginal Microbiota

COMPLETED PHASE4

Clinical Validation of the Molecular-Based GenePOC Carba Assay for the Detection and Differentiation of Carbapenemase Genes in Rectal Swab Samples.

NCT03680898

Carbapenem-Resistant Enterobacteriaceae

UNKNOWN NA

A Pilot Study To Assess The Impact Of A Camstent Coated Catheter On Clinical Bacteriuria

NCT04658719

Bacteriuria

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Vaginal Microbiota

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes