Vaginal Suppository Capsule Active for Vaginal Hygiene

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Vaginal HygieneVM-02 - Other
Eligibility
18+
Female
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Study Summary

The goal of this clinical trial is to assess the impact of a personal care product on vaginal health in a healthy participant population. The personal care product, VM-02, contains a prebiotic, postbiotic, and three distinct strains of Lactobacillus crispatus, a microbe commonly found in healthy females, together accounting for greater than 85% of known genes in this species. The intervention will be compared to a placebo intervention and will aim to assess the following in a healthy female population: Measure changes in the relative and absolute abundance of a bacterial species, Lactobacillus crispatus, in the vagina, compared the baseline (prior to use of the personal care product) to two time points after use. Observe changes in vaginal pH and self-reported discomfort from vaginal odor, compared the baseline to two time points after use. Determine the user experience of three variations of a personal care product administered in different formats to improve vaginal health and establish tolerability and user acceptability. Participants will use the personal care product according to a specific program as directed, conduct vaginal swab sampling, and answer questionnaires, each at eight time points.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 2 and 4 weeks after intervention

Week 4
Cytokine panel assays after administration of VM-02 at 5 x 10^8 CFU/dose
Participant self-reported questionnaire outcomes after administration of VM-02 at 5 x 10^8 CFU/dose
Self-reported pH values after administration of VM-02 at 5 x 10^8 CFU/dose
Vaginal colonization calculated by detection of each of 3 distinct Lactobacillus crispatus strains after administration of VM-02 at 5 x 10^8 CFU/dose using metagenomic sequencing and/or strain-specific PCR-based assays
Week 4
Safety and tolerability of VM-02 at 5 x 10^8 CFU/dose based on frequency and absolute number of patient reported adverse events

Trial Safety

Trial Design

4 Treatment Groups

Vaginal Suppository Capsule Active
1 of 4
Oral Capsule Active
1 of 4
Vaginal Suppository Tablet Active
1 of 4
Vaginal Suppository Capsule
1 of 4

Experimental Treatment

Non-Treatment Group

80 Total Participants · 4 Treatment Groups

Primary Treatment: Vaginal Suppository Capsule Active · Has Placebo Group · N/A

Vaginal Suppository Capsule Active
Other
Experimental Group · 1 Intervention: VM-02 · Intervention Types: Other
Oral Capsule Active
Other
Experimental Group · 1 Intervention: VM-02 · Intervention Types: Other
Vaginal Suppository Tablet Active
Other
Experimental Group · 1 Intervention: VM-02 · Intervention Types: Other
Vaginal Suppository Capsule
Other
PlaceboComparator Group · 1 Intervention: VM-02 Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 and 4 weeks after intervention

Who is running the clinical trial?

Seed HealthLead Sponsor
3 Previous Clinical Trials
213 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a female of reproductive age 18 years or older.
You have experienced six months of relatively regular menstrual cycles, ranging from 21 to 35 days in length.
You have agreed to abstain from utilizing certain intra-vaginal products during the course of this study.
You are amenable to utilizing an intra-vaginal suppository or dietary supplement during the study period.
You are prepared to perform self-administered vaginal swabs as instructed in the research.
You possess the linguistic proficiency and comprehension to read English, as well as consent in written form.