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Probiotic

Commercial Oral Vaginal Probiotic Competitor for Vaginal Hygiene

N/A

Waitlist Available

Research Sponsored by Seed Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 and 4 weeks after intervention

Awards & highlights

Study Summary

This trial will assess the impact of a personal care product on vaginal health in a healthy female population through swab sampling & questionnaires.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 and 4 weeks after intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 and 4 weeks after intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 and 4 weeks after intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

Other outcome measures

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

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Vaginal Suppository Tablet ActiveExperimental Treatment1 Intervention

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

Group II: Vaginal Suppository Capsule ActiveExperimental Treatment1 Intervention

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

Group III: Oral Capsule ActiveExperimental Treatment1 Intervention

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

Group IV: Commercial Oral Vaginal Probiotic CompetitorExperimental Treatment1 Intervention

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

Group V: Vaginal Suppository CapsulePlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Commercial Oral Probiotic Competitor

2022

N/A

~70

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Seed HealthLead Sponsor

4 Previous Clinical Trials

413 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies left to partake in this investigation?

"According to clinicaltrials.gov, the trial is in its recruitment phase and has been since it was first published on December 1st 2022. The study's information most recently updated on December 19th 20202."

Answered by AI

What is the aggregate amount of participants involved in this experiment?

"Affirmative, the details published on clinicaltrials.gov show that this medical trial is actively recruiting participants since December 1st 2022. It has been recently updated on December 19th and requires 80 patients to be enrolled at one single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Randomized, Double-blind, Placebo-controlled Trial Investigating the Role of a Personal Care Product on Vaginal Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05659745.