Randomized, Double-blind, Placebo-controlled Trial Investigating the Role of a Personal Care Product on Vaginal Health

NCT05659745 | Completed

• 1 other identifier: 20259
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vaginal Personal Care

Keywords

Lactobacillus crispatus; vaginal odor; vaginal health

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of VM-02 at 5 x 10^8 CFU/dose based on frequency and absolute number of patient reported adverse events

  Throughout intervention and subsequent 4 week period following last dose

Secondary Outcomes (1)

• 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

  2 and 4 weeks after intervention

Other Outcomes (3)

• Self-reported pH values after administration of VM-02 at 5 x 10^8 CFU/dose

  2 and 4 weeks after intervention

• Cytokine panel assays after administration of VM-02 at 5 x 10^8 CFU/dose

  2 and 4 weeks after intervention

• Participant self-reported questionnaire outcomes after administration of VM-02 at 5 x 10^8 CFU/dose

  2 and 4 weeks after intervention

Study Arms (5)

Vaginal Suppository Capsule

PLACEBO COMPARATOR

In the VM-02 Vaginal Suppository Capsule Placebo Arm, participants will take the test vaginal suppository capsule placebo as directed.

Other: VM-02 Placebo

Vaginal Suppository Capsule Active

EXPERIMENTAL

In the VM-02 Vaginal Suppository Capsule Active Arm, participants will take a test vaginal suppository capsule as directed.

Other: VM-02

Vaginal Suppository Tablet Active

EXPERIMENTAL

In the VM-02 Vaginal Suppository Tablet Active Arm, participants will take a test vaginal suppository tablet as directed.

Other: VM-02

Oral Capsule Active

EXPERIMENTAL

In the VM-02 Oral Capsule Active Arm, participants will take a test oral capsule as directed.

Other: VM-02

Commercial Oral Vaginal Probiotic Competitor

OTHER

In the Commercial Over-The-Counter (OTC) Oral Probiotic Competitor Arm, participants will take an over-the-counter competitor product as directed.

Dietary Supplement: Commercial Oral Probiotic Competitor

Interventions

VM-02 OTHER

VM-02 is a personal care product for vaginal health.

Oral Capsule Active; Vaginal Suppository Capsule Active; Vaginal Suppository Tablet Active

Commercial Oral Probiotic Competitor DIETARY_SUPPLEMENT

Commercial Oral Vaginal Probiotic Competitor is a personal care product for vaginal health.

Commercial Oral Vaginal Probiotic Competitor

VM-02 Placebo OTHER

VM-02 Placebo is a personal care product placebo for vaginal health.

Vaginal Suppository Capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Reproductive age women aged ≥ 18.
• History of regular menses every 21-35 days for six months prior to the study.
• Agreement not to use specified intra-vaginal products during the study product use.
• Willing to use an intra-vaginal suppository or dietary supplement during the study period.
• Willing to complete vaginal swabs on themselves as directed in the study.
• Ability to understand and read English and provide written consent.

You may not qualify if:

• Pregnancy or planned pregnancy in the next 6 months.
• Two or more amenorrheic months in the past 6 months.
• Lives in the state of New York.
• Allergy to any components of the supporting or excipient ingredients in test formulation capsules, tablets, placebos or over-the-counter competitor product.

Sponsors & Collaborators

• Seed Health: lead

Study Sites (1)

Seed Health

Venice, California, 90291, United States

Location

Related Publications (1)

• Ravel J, Simmons S, Jaswa EG, Gottfried S, Greene M, Kellogg-Spadt S, Gevers D, Harper DM. Impact of a multi-strain L. crispatus-based vaginal synbiotic on the vaginal microbiome: a randomized placebo-controlled trial. NPJ Biofilms Microbiomes. 2025 Aug 9;11(1):158. doi: 10.1038/s41522-025-00788-6.

  PMID: 40783570 DERIVED

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to this study being double-blind, participants will not know if they are in the condition with the test product or the placebo. Neither the test products nor the placebo used during the study will be labeled in any way that will indicate whether participants are taking the placebo or the test product. Participants will just know there is a chance they were randomized into a placebo or test product arm of the study. As mentioned above, only the Research Coordinator will know which group the participant is randomized into. The PI will remain blinded throughout the study.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 21, 2022
• Study Start: December 5, 2022
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-01

Locations

US (1)