Vaginal Live Biotherapeutic for Bacterial Vaginosis

Not yet recruiting at 1 trial location

Overseen By Disebo Potloane, MD

Age: 18 - 65

Sex: Female

Trial Phase: Phase < 1

Sponsor: Caroline Mitchell

Must not be taking: Antibiotics, Probiotics

Disqualifiers: Infection requiring antibiotics, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LC106, a live biotherapeutic (a beneficial bacteria-based treatment) inserted vaginally. The goal is to evaluate its effectiveness and behavior in the body over time for those with bacterial vaginosis, a common vaginal infection. Participants must have previously participated in the VIBRANT study and have a diagnosis of bacterial vaginosis. This study aims to gather more information to develop effective treatments for this condition. As an Early Phase 1 trial, participants will be among the first to help researchers understand how this new treatment works in people.

Will I have to stop taking my current medications?

The trial requires that you have not used oral or vaginal antibiotics or probiotics in the 30 days before screening. If you are currently taking these, you would need to stop before participating.

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

Research has shown that LC106, a treatment containing the beneficial bacteria Lactobacillus crispatus, has undergone safety studies. One study examined the safety of LC106 and the detection of the bacteria in participants. Researchers aimed to determine if the treatment was well-tolerated and if it caused any issues.

The results indicated that LC106 was generally well-tolerated, with most participants not experiencing major side effects. This suggests that LC106 might be safe for humans, but further research is necessary to confirm this. As this is an early-stage trial, safety remains a primary focus, and any issues will be closely monitored. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for bacterial vaginosis, which typically involve antibiotics, LC106 is a live biotherapeutic. This means it uses live bacteria to help restore the natural balance of microbes in the vagina. Researchers are excited about LC106 because it offers a potentially more natural and targeted approach to treating bacterial vaginosis, with the hope of reducing recurrence rates and minimizing side effects associated with antibiotics. Additionally, LC106 is administered directly in the clinic for just three days, which might offer a quicker, more convenient treatment option.

What evidence suggests that this treatment might be an effective treatment for bacterial vaginosis?

Research shows that LC106, the treatment under study in this trial for bacterial vaginosis (BV), aims to restore healthy bacteria in the vagina. BV often occurs when harmful bacteria outnumber beneficial ones. Studies on similar treatments, such as LACTIN-V, have shown a reduced chance of BV returning 12 and 24 weeks after treatment. LC106 uses a mix of different beneficial bacteria to help balance the vaginal environment. Early results suggest that these treatments can effectively reduce the recurrence of BV. ^{1 6 7 8 9}

Who Is on the Research Team?

Caroline M Mitchell, MD, MPH

Principal Investigator

Massachusetts General Hospital

Disebo Potloane, MD

Principal Investigator

Centre for the AIDS Programme of Research in South Africa

Are You a Good Fit for This Trial?

This trial is for women who were part of the VIBRANT study, received active LBP treatment, and have a Nugent score indicating mild to moderate bacterial vaginosis. They shouldn't have used any probiotics or antibiotics orally or vaginally in the last 30 days.

Inclusion Criteria

Previous participant in the VIBRANT study, randomized to active LBP

Nugent score 4-10

Exclusion Criteria

I have used an oral or vaginal probiotic in the last 30 days.

Infection requiring antibiotics detected on screening labs

I have not taken any antibiotics by mouth or vaginally in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LC106 in the clinic for three consecutive days

1 week

3 visits (in-person)

Follow-up

Participants are monitored for colonization and response consistency

5 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LC106

Trial Overview

The trial is testing LC106, a vaginal live biotherapeutic product with multiple strains of Lactobacillus Crispatus. It's an open-label, single-arm Phase Ib study focusing on how well this intervention colonizes and its consistency over time.

How Is the Trial Designed?

Group I: Re-challenge Experimental Treatment 1 Intervention

Administration of LC106 in clinic, for three days

Who Is Running the Clinical Trial?

Caroline Mitchell

Lead Sponsor

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12495413/

Randomized trial of multi-strain Lactobacillus crispatus ...

Clinically, women treated with LACTIN-V had a significantly lower risk for recurrent BV at both 12 and 24 weeks. These results suggest that 1) vaginal ...

2.

microbiometimes.com

microbiometimes.com/the-clinical-journey-of-a-novel-lbp-for-bacterial-vaginosis-developed-by-mgh-biose-industrie/

The Clinical Journey of a Novel LBP for Bacterial Vaginosis ...

The trio described the development of two multi-strain consortium LBPs targeting BV, LC106 and LC115. Both drug products contain multiple ...

3.

malacards.org

malacards.org/card/bacterial_vaginosis

Bacterial Vaginosis

Integrated disease information for Bacterial Vaginosis including associated genes, mutations, phenotypes, pathways, drugs, and more - integrated from 78 ...

4.

researchgate.net

researchgate.net/publication/224053219_Efficacy_of_Oral_Metronidazole_with_Vaginal_Clindamycin_or_Vaginal_Probiotic_for_Bacterial_Vaginosis_Randomised_Placebo-Controlled_Double-Blind_Trial

Efficacy of Oral Metronidazole with Vaginal Clindamycin or ...

Six-month retention rates were 78% (n = 351). One-month BV recurrence (NS 7-10) rates were 3.6% (5/140), 6.8% (9/133) and 9.6 ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8388924/

Comparative Effectiveness of Treatments for Bacterial ...

This meta-analysis included a final set of 25 eligible studies with a total of 57 RCTs and compared the effectiveness of BV treatments among non-pregnant and ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06135974

Study Details | NCT06135974 | Vaginal lIve Biotherapeutic ...

In this study, we will compare safety and biologic effects of two formulations of a consortia of L. crispatus strains, and a variety of dosing strategies in ...

7.

medrxiv.org

medrxiv.org/content/10.1101/2025.09.18.25336053v1

A Phase 1 randomized trial of multi-strain vaginal L. ...

... LC106 was initiated on day 3 of metronidazole treatment. The primary outcomes were safety and detection of any L. crispatus strains ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41050878/

Randomized trial of multi-strain Lactobacillus crispatus ...

Randomized trial of multi-strain Lactobacillus crispatus vaginal live biotherapeutic products after antibiotic therapy for bacterial vaginosis: study protocol ...

9.

papers.ssrn.com

papers.ssrn.com/sol3/papers.cfm?abstract_id=5261044

Randomized Trial of Multi-Strain Lactobacillus crispatus ...

This is a Phase 1, randomized, placebo-controlled trial of vaginal live biotherapeutic products (LBP) after antibiotic treatment for BV to establish ...