A randomized, placebo-controlled trial to assess the Pharmacokinetics and Pharmacodynamics of a novel synbiotic dietary supplement for vaginal health.
This is a randomized, double-blind, placebo-controlled, decentralized clinical trial that will enroll approximately 200 healthy women aged 21-60 years old who meet all eligibility criteria. Eligible participants will be stratified based on key factors. Following stratification, participants will be randomized to one of the study arms (placebo or VV-01 product) using block randomization. Participants will have a 1:1 chance of receiving the active study product or the placebo. Participants will receive study kits containing the study product, administration supplies, biomarker self-collection materials, and comprehensive instructions for product use and sample collection. The duration of the study for each participant will be approximately 2 weeks following enrollment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
200
Vaginal Health Placebo Control Participants will orally ingest Vaginal Health Placebo Control once daily as directed for a period of 2 weeks
Product 1 Participants will orally ingest Vaginal Health Active Product 1 once daily as directed for a period of 2 weeks.
Radicle Science Inc.
Del Mar, California, United States
Colonization of VV-01 probiotic strains in the vagina
Colonization of VV-01 probiotic strains in the vagina assessed using strain-specific qPCR from vaginal swabs
Time frame: Baseline to Day 14
Vaginal microbial ecosystem structure
Structure of the vaginal microbiome assessed by metagenomic sequencing of vaginal swabs
Time frame: Baseline to Day 14
Biogenic amines production capability in the vaginal microbiome
Biogenic amines production capability assessed by metagenomic sequencing (functional genomics) of vaginal swabs
Time frame: Baseline to Day 14
Safety and tolerability
Safety and tolerability assessed through observation of serious adverse events
Time frame: Baseline to Day 14
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