MedTrace Logo

FB101 Intervention in Women Screened to Have Vaginal Dysbiosis

NCT05114031 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-05-03

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 metagenomic sequencing of a vaginal swab sample.

Conditions

  • Vaginal Flora Imbalance

Interventions

OTHER

FB101

Microbial intervention using product FB101

OTHER

Placebo

Saline water

Sponsors & Collaborators

  • Freya Biosciences ApS

    lead INDUSTRY

Principal Investigators

  • Fergus McCarthy, PHD, MD · Atlantia Food 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
2021-10-20
Primary Completion
2022-10-15
Completion
2023-02-01

Countries

  • Ireland

Study Locations

More Related Trials

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 NCT05114031 on ClinicalTrials.gov