NCT05850078

FB101 Intervention in Women Screened to Have Vaginal Dysbiosis (Dyscover-3)

Vaginal Microbiome Transplant in Asymptomatic Healthy Volunteers, Who Have Undergone Vaginal Microbiome Screening - a Randomised, Double-blind, Placebo-controlled Three-arm Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Freya Biosciences ApS · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study will explore and map the potential shifts in vaginal microbiomes as a consequence of a microbial intervention with product FB101 in healthy, asymptomatic volunteer women screened to have vaginal dysbiosis based on criteria defined by quantitative polymerase chain reaction (qPCR) analysis of a vaginal swab sample.

Detailed description

This study will explore and map the potential shifts in vaginal microbiomes as a consequence of a microbial intervention with product FB101 in healthy, asymptomatic volunteer women screened to have vaginal dysbiosis based on criteria defined by qPCR analysis of a vaginal swab sample. A dose of FB101 will be given on 2 different days and subjects will be followed for changes in their vaginal microbiomes until approximately 3 months after the first FB101 dose. Two different dilutions will be tested of FB101 in 2 different active arms. The study will also have a third arm receiving placebo product. In addition, an antiseptic vaginal wash will be performed before the first dose of FB101/placebo in all 3 study arms. Randomisation ratios will be 1:1:1. The study includes a screening visit where all criteria for participation are checked and a vaginal swab is obtained to check if pre-defined dysbiosis criteria are met based on qPCR analysis of key vaginal bacterial species. If, and when, all criteria are confirmed, a baseline visit is scheduled to be performed around day 14 in the same menstrual cycle of each individual subject. Besides baseline assessments, the subject is randomised to active FB101 or placebo in a ratio of 1(active, FB101):1(active, diluted FB101): 1(placebo) and the first dose is given. At visit 3 (performed the day after baseline visit the following dose is given. In total, 5 follow-up visits are scheduled to occur for a period of up to 3 months after the first dose. All follow-up visits will be scheduled to occur around day 14 in the subject's menstrual cycle with one menstrual cycle in between visits. At follow up visits, close safety monitoring will be performed as well as metagenomic sequencing assessment of the microbiota in a vaginal swab.

Conditions

• Vaginal Flora Imbalance

Interventions

Type	Name	Description
OTHER	FB101	Intervention will test effects on changes to the vaginal microbiome of FB101 versus diluted FB101 versus placebo

Timeline

• Start date: 2023-05-18
• Primary completion: 2024-08-29
• Completion: 2025-01-24
• First posted: 2023-05-09
• Last updated: 2025-12-10

Locations

1 site across 1 country: Ireland