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

NCT05850078 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2025-12-10

No results posted yet for this study

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.

Conditions

  • Vaginal Flora Imbalance

Interventions

OTHER

FB101

Intervention will test effects on changes to the vaginal microbiome of FB101 versus diluted FB101 versus placebo

Sponsors & Collaborators

  • Freya Biosciences ApS

    lead INDUSTRY

Principal Investigators

  • Fergus McCarthy, PhD, MD · Atlantia Clinical Trials

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-18
Primary Completion
2024-08-29
Completion
2025-01-24

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05850078 on ClinicalTrials.gov