NCT06135974

Vaginal lIve Biotherapeutic RANdomized Trial

Phase 1 Trial of Multi-strain Lactobacillus Crispatus Vaginal Live Biotherapeutic Product

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomized clinical trial is to evaluate safety and biologic effect of a multi-strain vaginal L. crispatus live biotherapeutic product (LBP) in people receiving antibiotic treatment for bacterial vaginosis (BV). The main question\[s\] it aims to answer are whether the intervention is safe, and whether the strains of L. crispatus will colonize recipients' vagina. The study will evaluate one LBP with 6 strains of L. crispatus (LC106) and one LBP with 15 strains (LC115) vs. placebo. Participants will: * be treated with oral antibiotics for BV * receive 7 days of vaginal study product * collect daily home swabs and make short daily diary entries for 5 weeks, including the week of antibiotic treatment and the week of study product treatment. Researchers will compare the 3 groups receiving different dosing strategies of LC106 and 1 group receiving LC115 vs. 1 group receiving placebo to see if the live biotherapeutic strains colonize the vagina after antibiotic treatment for BV.

Detailed description

This is a Phase I randomized trial of a novel live biotherapeutic intervention containing multiple strains of L. crispatus. L. crispatus is a species of Lactobacillus commonly found in the human vagina, which is associated with optimal reproductive health outcomes. Detection of, and dominance of the community by, L. crispatus is associated with lower risk for bacterial vaginosis (BV), but no intervention to date has demonstrated the ability to durably shift the vaginal microbiome to L. crispatus dominance in a majority of treated people. 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 women with BV who receive antibiotic treatment. Our primary outcome is colonization with any of the L. crispatus strains contained in the live biotherapeutic product. All participants will have menses suppressed with either injectable progesterone contraception or continuous oral contraceptive pills for the duration of the study. All participants will receive 7 days of oral metronidazole (500mg twice daily) and will be randomized to one of five groups: 1. Placebo daily for 7d after metronidazole treatment 2. LC-106 daily for 7d after metronidazole treatment 3. LC-106 daily for 3d + 4 days of placebo, starting after metronidazole treatment 4. LC-106 daily for 7d, starting on day 3 of metronidazole treatment 5. LC-115 daily for 7d after metronidazole treatment

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
DRUG	LC106	Tablet containing at least 2 x 10\^6 CFU/tablet, and comprised of 6 strains of Lactobacillus crispatus
DRUG	LC115	Tablet containing at least 2 x 10\^6 CFU/tablet, and comprised of 15 strains of Lactobacillus crispatus
DRUG	Placebo	Vaginal tablets containing primarily microcrystalline cellulose and no live bacteria
DRUG	Metronidazole Oral	Metronidazole tablet orally twice daily for 7 days

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-12-26
• Completion: 2025-02-18
• First posted: 2023-11-18
• Last updated: 2025-03-25

Locations

2 sites across 2 countries: United States, South Africa

Regulatory

• FDA-regulated drug study