Synbiotic Supplement for Vaginal Health

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new synbiotic supplement, VV-01, which combines probiotics and prebiotics to enhance vaginal health. Researchers aim to understand the supplement's effects in the body and its potential benefits. The trial includes two groups: one takes the supplement, and the other takes a placebo (a non-active pill for comparison). Women with a vagina who are healthy and have a regular or somewhat regular menstrual cycle may qualify, but they must not have active vaginal infections or use certain vaginal products during the study. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on vaginal health.

Do I have to stop taking my current medications for the trial?

The trial requires you to stop using antibiotics, antifungals, and any probiotic, prebiotic, or synbiotic products at least 4 weeks before enrolling. You also need to avoid certain intravaginal products during the study. If you're on chronic oral steroids or have serious medical conditions requiring treatment, you may not be eligible.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that the synbiotic supplement VV-01 is generally safe for use. In earlier studies, participants experienced no negative effects with similar supplements, indicating a good safety record. Specifically, several studies found that multi-strain vaginal synbiotics, like VV-01, are well-tolerated and usually do not cause harmful side effects. This makes VV-01 a promising option for those considering participation in a clinical trial.12345

Why are researchers excited about this trial?

Unlike the standard treatments for vaginal health, which often include antifungals and antibiotics, VV-01 is a synbiotic supplement. Synbiotics combine probiotics and prebiotics, which aim to support the growth of beneficial bacteria. Researchers are excited about VV-01 because it offers a natural approach, potentially reducing the need for medications with harsh side effects. This supplement could enhance the vaginal microbiome, offering a unique and holistic alternative to maintaining vaginal health.

What evidence suggests that this synbiotic supplement is effective for vaginal health?

Research has shown that the multi-strain synbiotic VV-01, which includes L. crispatus, effectively supports vaginal health. Studies have found that it increases the amount of beneficial bacteria, particularly L. crispatus, in the vagina. This promotes a healthier bacterial balance, crucial for preventing infections and maintaining vaginal health. Previous research demonstrated that similar synbiotics can reduce symptoms like unusual discharge and pain during urination. These findings suggest that VV-01, which participants in this trial may receive, could be a promising option for improving vaginal health by maintaining a balanced bacterial environment.13678

Who Is on the Research Team?

SH

Susan Hewlings

Principal Investigator

Radicle Science

Are You a Good Fit for This Trial?

This trial is for healthy women aged 21-60 living in the US, who were assigned female at birth and have a vagina. Participants must be willing to take an oral capsule, collect their own vaginal samples, avoid using intravaginal products during the study, and be able to read English.

Inclusion Criteria

I am willing to take a capsule and not know if it's the real drug or a placebo.
* Willing to self-collect vaginal swabs and pH samples
I am willing to avoid using any intravaginal products during the study.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either the VV-01 product or placebo for 2 weeks

2 weeks
Decentralized trial with self-collection of samples

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • VV-01

Trial Overview

The study compares a new synbiotic oral supplement (VV-01) designed for vaginal health against a placebo. Participants are randomly assigned to either group without knowing which one they receive.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Active VV-01Active Control1 Intervention
Group II: Placebo ControlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Radicle Science

Lead Sponsor

Trials
24
Recruited
46,200+

Citations

Impact of a multi-strain L. crispatus-based vaginal synbiotic on ...

Results indicate that L. crispatus successfully colonized individuals who received the multi-strain synbiotic vaginal tablet, and that ...

Efficacy and Safety of MED-01 Probiotics on Vaginal Health

The results of the symptom questionnaire evaluation demonstrated that vaginal discharges and dysuria pain were significantly reduced in the MED-01-intake group ...

A Novel Multi-strain Vaginal Synbiotic is Effective in ...

This research letter describes the results of a clinical trial of a novel vaginal synbiotic comprising three L. crispatus strains and a ...

Reference Library - VS01 - Seed

Results revealed a vaginal tablet formulation of VS-01™ demonstrated a significant increase in L. crispatus relative abundance, and the highest rates of ...

New Clinical Data Highlights Efficacy of Seed Health's VS ...

Data from a randomized, placebo-controlled clinical trial demonstrated the superior efficacy of VS-01™ in cultivating a stable and healthy ...

Reference Library - VS01 - Seed

Overall, all formulations were well-tolerated with a favorable safety profile. This study is the first to demonstrate that a multi-strain vaginal synbiotic (VS- ...

Efficacy and Safety of MED-01 Probiotics on Vaginal Health

No adverse events to the test food supplements were observed in the participants. These results confirmed that MED-01 can be used as a probiotic for treating BV ...

New Clinical Data Highlights Efficacy of Seed Health's VS- ...

Data from a randomized, placebo-controlled clinical trial demonstrated the superior efficacy of VS-01™ in cultivating a stable and healthy ...