FB101 Intervention in Women Screened to Have Vaginal Dysbiosis — DYSCOVER-1  

Vaginal Flora Imbalance Clinical Trial

Official title: FB101 Intervention in Asymptomatic Healthy Volunteers Who Have Undergone Vaginal Microbiome Screening - a Randomised, Double-blind, Placebo-controlled Study

Status Completed

Clinical Trial 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 metagenomic sequencing of a vaginal swab sample.

Clinical Trial 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 metagenomic sequencing of a vaginal swab sample. A dose of FB101 will be given on 3 different days and subjects will be followed for changes in their vaginal microbiomes until approximately 6 months after the first FD101 dose. 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 metagenomic sequencing. If, and when, all criteria are confirmed, a baseline visit, visit 2, is scheduled to be performed around day 8 of the following menstrual cycle of each individual subject. Besides baseline assessments, the subject is randomised to active FB101 or placebo in a ratio of 3(active): 1(placebo) and the first dose is given. At visit 3 and 4 (performed on day 9 and 10 in the same menstrual cycle as Visit 2) the following 2 doses are given. In total, 7 follow-up visits (visit 5-11) are scheduled to occur for a period of up to 6 months after the first dose. All follow-up visits will be scheduled to occur around day 8 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. ;

Related Conditions & MeSH terms

• Vaginal Flora Imbalance

• NCT number: NCT05114031
• Study type: Interventional
• Source: Freya Biosciences ApS
• Status: Completed
• Phase: N/A
• Start date: October 20, 2021
• Completion date: February 1, 2023