Collection of Vaginal Microbiota Samples (VAGINOTYPE)

NCT06486519 | Completed

• 2 other identifiers: L-0312022-A01997-36
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Vaginal Microbiota

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Lallemand Health Solutions: lead
• BioFortis: collaborator

Study Sites (2)

Biofortis, Unité d'Investigation Clinique

Paris, 75012, France

Location

Biofortis, Unité d'Investigation Clinique

Saint-Herblain, 44800, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Vaginal swab

MeSH Terms

Conditions

Urinary Tract Infections; Vaginitis

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Vaginal Diseases; Genital Diseases, Female; Genital Diseases

Study Officials

• Isabelle Metreau, MD

  Biofortis, Unité d'Investigation Clinique de Saint-Herblain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 3, 2024
• Study Start: May 14, 2024
• Primary Completion: September 11, 2024
• Study Completion: September 11, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)