NCT02415868

Ex Vivo High-Throughput Assay for Vaginal Community Post-menopausal Women

Development of an Ex-vivo High-throughput Screening Assay for the Vaginal Microbiota of Post-menopausal Women

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Kimberly-Clark Corporation · Industry
• Sex: Female
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This purpose of this study is to collect vaginal microbial samples of postmenopausal women to assess the optimal conditions for cultivation and storage of the vaginal microbiota. These samples will subsequently be used to develop a high-throughput assay that mimicks the vaginal microbial community of postmenopausal women. This assay will be used to select and screen compounds that can affect the vaginal microbiota and subsequently affect related symptoms such as vaginal dryness.

Detailed description

Vaginal swabs will be collected from post-menopausal women (5 women vaginal pH ≤4.5 and 5 women with vaginal pH≥5.5), aged 45 - 75, with at least 12 months of amenorrhea. Enough women will be screened to ensure five women for each pH range. Using a speculum, the mid lateral vaginal wall is made visible, samples will be collected by the physician or nurse using a flocked swab. After collection, vaginal swabs will be stored immediately in adequate liquid medium at 4ºC and will be transported to the lab within 7 hours after sampling for further storage and culture of the material. The vaginal microbiota of post-menopausal women with a vaginal pH of ≤ 4.5 and ≥ 5.5 will be characterized and compared using 16S ribosomal ribonucleic acid (rRNA) sequencing. In additional, optimal conditions for cultivation and storage of the vaginal microbiota will be examined for use in assays mimicking the vaginal microbial community of postmenopausal women.

Conditions

• Postmenopausal Syndrome

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2015-04-14
• Last updated: 2016-02-23

Locations

1 site across 1 country: Netherlands