What is the mechanism of action of this treatment?

The most common treatments for Bacterial Vaginosis (BV) include antibiotics like metronidazole and clindamycin, which work by reducing the overgrowth of harmful anaerobic bacteria in the vagina. However, these treatments can also disrupt beneficial bacteria, leading to potential recurrence. Probiotics, such as the L. crispatus live biotherapeutic product, aim to restore a healthy vaginal microbiome by colonizing the vagina with beneficial bacteria. This helps maintain an acidic environment that inhibits pathogenic bacteria, reducing recurrence risk and promoting long-term vaginal health.

What side effects are associated with this type of intervention?

Common treatments for Bacterial Vaginosis (BV) include antibiotics like metronidazole and clindamycin, which can cause side effects such as nausea, diarrhea, and a metallic taste. Probiotic treatments, such as those involving L. crispatus, aim to restore a healthy vaginal microbiome and are generally well-tolerated. However, they may cause mild gastrointestinal symptoms like bloating and gas. In rare cases, probiotics can lead to infections, particularly in immunocompromised individuals. Overall, both antibiotics and probiotics are considered safe for most patients when used appropriately.

What other types of research exist?

Promising novel alternatives to L. crispatus live biotherapeutic products for treating bacterial vaginosis include multi-strain probiotic formulations containing Lactobacillus reuteri, Lactobacillus rhamnosus, and Lactobacillus acidophilus. These strains have shown potential in clinical studies for restoring a healthy vaginal microbiome. Additionally, synbiotics, which combine probiotics with prebiotics like galacto-oligosaccharides (GOS) and fructo-oligosaccharides (FOS), have demonstrated efficacy in improving vaginal health by enhancing the growth and activity of beneficial bacteria.

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Antibiotic

Live Biotherapeutic Product for Bacterial Vaginosis (VIBRANT Trial)

Q: What prior FDA approvals exist?

The FDA has approved several treatments for Bacterial Vaginosis, primarily focusing on antibiotics such as metronidazole, clindamycin, and tinidazole. These treatments aim to eliminate the pathogenic bacteria causing the infection. However, there is growing interest in using probiotics to restore a healthy vaginal microbiome by colonizing the vagina with beneficial bacteria. One such approach involves the use of Lactobacillus crispatus, which is currently being studied in clinical trials. This method aims to re-establish the natural balance of vaginal flora, potentially offering a more sustainable solution to prevent recurrent BV.

Phase < 1

Recruiting

Led By Caroline Mitchell, MD, MPH

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Premenopausal individuals, 18-40 years old

Be between 18 and 65 years old

Must not have

Diagnosed with cervicovaginal infection (inclusive of gonorrhoeae, chlamydia, trichomonas) within the 30 days prior (or at enrollment visit). Yeast and bacterial vaginosis are not exclusionary

Vulvovaginal candidiasis (positive microscopy at enrollment)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over 12 weeks

Summary

This trial tests whether adding beneficial bacteria called L. crispatus to the vagina can help women with bacterial vaginosis who are taking antibiotics. The goal is to see if these good bacteria can safely and effectively establish themselves in the vagina and maintain a healthy balance. Lactobacillus crispatus has been studied in various clinical trials for its potential to prevent bacterial vaginosis recurrence and restore normal vaginal flora.

Who is the study for?

This trial is for premenopausal individuals aged 18-40 with bacterial vaginosis, as confirmed by specific criteria. They must be willing to follow the study procedures, not pregnant or breastfeeding, HIV negative, and on certain contraceptives. Exclusions include significant reproductive tract diseases, recent antibiotic use or infections other than BV, certain medication use within the last month, and any condition that may affect participation.

What is being tested?

The trial tests two vaginal live biotherapeutic products (LBPs) containing different strains of L. crispatus (LC106 & LC115) against a placebo in people treated with antibiotics for BV. It aims to see if these LBPs are safe and can colonize the vagina post-treatment.

What are the potential side effects?

Potential side effects aren't detailed but could include reactions related to introducing live bacteria into the body's system such as local irritation or infection. The safety profile will be closely monitored given it's a new treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a premenopausal person aged between 18 and 40.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I was diagnosed with a cervicovaginal infection, excluding yeast and bacterial vaginosis, within the last 30 days.

Select...

I have a yeast infection confirmed by a lab test.

Select...

I am allergic to or cannot take oral metronidazole.

Select...

I am in menopause due to surgery or because my periods stopped after chemotherapy.

Select...

I haven't used any experimental drugs or treatments in the last year.

Select...

I am currently using testosterone for a health condition.

Select...

I have taken antibiotics in the last 30 days.

Select...

I have had a hysterectomy.

Select...

I have had significant diseases of the female reproductive organs, including cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~over 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and over 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse events

Detection of LBP strains by metagenomic sequencing

Secondary study objectives

Alpha and beta diversity of the microbial community

Kinetics of colonization

Non-iners Lactobacillus dominance and abundance

+2 more

Other study objectives

Comparison of detection of LBP strains by metagenomics between US and South Africa

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: LC115Experimental Treatment2 Interventions

Vaginal live biotherapeutic product with 15 strains of L. crispatus, administered daily for 7 days after antibiotic treatment

Group II: LC106 7 days, early startExperimental Treatment2 Interventions

Vaginal live biotherapeutic product with 6 strains of L. crispatus, administered daily for 7 days starting on the 3rd day of antibiotic treatment

Group III: LC106 7 daysExperimental Treatment2 Interventions

Vaginal live biotherapeutic product with 6 strains of L. crispatus, administered daily for 7 days after antibiotic treatment

Group IV: LC106 3 daysExperimental Treatment2 Interventions

Vaginal live biotherapeutic product with 6 strains of L. crispatus, administered daily for 3 days after antibiotic treatment and packaged with 4 tablets of placebo to maintain masking (so a total of 7 tablets)

Group V: PlaceboPlacebo Group2 Interventions

Vaginal placebo tablet administered daily for 7 days starting after antibiotic treatment

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metronidazole Oral

2019

Completed Phase 4

~190

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Bacterial Vaginosis (BV) include antibiotics like metronidazole and clindamycin, which work by reducing the overgrowth of harmful anaerobic bacteria in the vagina. However, these treatments can also disrupt beneficial bacteria, leading to potential recurrence. Probiotics, such as the L. crispatus live biotherapeutic product, aim to restore a healthy vaginal microbiome by colonizing the vagina with beneficial bacteria. This helps maintain an acidic environment that inhibits pathogenic bacteria, reducing recurrence risk and promoting long-term vaginal health.