Status:
COMPLETED
Collection of Vaginal Microbiota Samples (VAGINOTYPE)
Lead Sponsor:
Lallemand Health Solutions
Collaborating Sponsors:
BioFortis
Conditions:
Vaginal Microbiota
Eligibility:
FEMALE
18-60 years
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. El...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 14 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 11 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06486519
Start Date
May 14 2024
End Date
September 11 2024
Last Update
September 19 2024
Active Locations (2)
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1
Biofortis, Unité d'Investigation Clinique
Paris, France, 75012
2
Biofortis, Unité d'Investigation Clinique
Saint-Herblain, France, 44800