- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05659745
Randomized, Double-blind, Placebo-controlled Trial Investigating the Role of a Personal Care Product on Vaginal Health
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The vaginal microbiome is a dynamic microecosystem that undergoes fluctuations during the female menstrual cycle and at various life stages from puberty to menopause. A healthy vaginal microbiome is dominated by Lactobacillus which regulates vaginal pH, produces antimicrobial compounds, and significantly influences host immune response. The purpose of this study is to determine whether vaginal health can be influenced by a novel personal care product comprised of a Lactobacillus postbiotic, prebiotic, and multiple strains of Lactobacillus crispatus predictive of a stable vaginal microbiome.
This study will be a randomized double-blind, placebo-controlled intervention that will examine the safety and tolerability of a personal care product for vaginal health, VM-02. This pilot study will last for the duration of two complete menstrual cycles. Data will be collected via participant virtual questionnaires and vaginal swabs.
Participants are randomized as follows:
A two-arm randomized, double-blind, placebo-controlled study to evaluate VM-02 as a vaginal suppository capsule.
Arm #1: Vaginal application of single-use applicators filled with a vaginal suppository capsule at 5 x 10^8 CFU/dose. The study product will be administered once daily for 7 consecutive days, followed by once weekly application over 2 consecutive additional weeks.
Arm #2: Vaginal application of single-use applicators filled with a vaginal suppository placebo capsule. The study product will be administered once daily for 7 consecutive days, followed by once weekly application over 2 consecutive additional weeks.
Three additional arms are included to quantify the impact of an alternative formulation and user experience.
Arm #3: Vaginal application of single-use applicators filled with vaginal suppository tablet at 5 x 10^8 CFU/dose. The study product will be administered on Days 1,4,7,14,21.
Arm #4: Oral administration of capsule at 5 x 10^8 cfu/dose. The study product will be administered daily for 30 consecutive days.
Arm #5: Oral administration of commercially available over-the-counter oral capsule at 5 x 10^8 CFU/dose. The study product will be administered daily for 30 consecutive days.
Colonization rate of 3 distinct Lactobacillus crispatus after administration of VM-02 will be assessed with PCR and DNA sequence analysis.
Researchers will compare groups who received active product with those who received a placebo (a look-alike substance that contains no active drug) to determine product safety and any possible side effects, see if the amount of the bacterial species, Lactobacillus crispatus, changes (either increases or decreases) in response to the treatment, and to determine any impacts on self-reported odor and vaginal health.
A total of 80 participants will be recruited for this study. All participants will be supported and tracked through the various stages of the study virtually. All biomarker swabs that are taken by participants will be returned via pre-paid envelopes provided by the research team and all survey information will be collected online. No in-person visits will be required. Participants who are unwilling to follow the study protocol will be removed from the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dirk Gevers
- Email: ct_trials@seed.com
Study Locations
-
-
California
-
Venice, California, United States, 90291
- Seed Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Vaginal Suppository Capsule
In the VM-02 Vaginal Suppository Capsule Placebo Arm, participants will take the test vaginal suppository capsule placebo as directed.
|
VM-02 Placebo is a personal care product placebo for vaginal health.
|
Experimental: Vaginal Suppository Capsule Active
In the VM-02 Vaginal Suppository Capsule Active Arm, participants will take a test vaginal suppository capsule as directed.
|
VM-02 is a personal care product for vaginal health.
|
Experimental: Vaginal Suppository Tablet Active
In the VM-02 Vaginal Suppository Tablet Active Arm, participants will take a test vaginal suppository tablet as directed.
|
VM-02 is a personal care product for vaginal health.
|
Experimental: Oral Capsule Active
In the VM-02 Oral Capsule Active Arm, participants will take a test oral capsule as directed.
|
VM-02 is a personal care product for vaginal health.
|
Other: Commercial Oral Vaginal Probiotic Competitor
In the Commercial Over-The-Counter (OTC) Oral Probiotic Competitor Arm, participants will take an over-the-counter competitor product as directed.
|
Commercial Oral Vaginal Probiotic Competitor is a personal care product for vaginal health.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability of VM-02 at 5 x 10^8 CFU/dose based on frequency and absolute number of patient reported adverse events
Time Frame: Throughout intervention and subsequent 4 week period following last dose
|
Throughout intervention and subsequent 4 week period following last dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: 2 and 4 weeks after intervention
|
2 and 4 weeks after intervention
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Self-reported pH values after administration of VM-02 at 5 x 10^8 CFU/dose
Time Frame: 2 and 4 weeks after intervention
|
2 and 4 weeks after intervention
|
Cytokine panel assays after administration of VM-02 at 5 x 10^8 CFU/dose
Time Frame: 2 and 4 weeks after intervention
|
2 and 4 weeks after intervention
|
Participant self-reported questionnaire outcomes after administration of VM-02 at 5 x 10^8 CFU/dose
Time Frame: 2 and 4 weeks after intervention
|
2 and 4 weeks after intervention
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20259
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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