Vaginal lIve Biotherapeutic RANdomized Trial

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.

Conditions

• Bacterial Vaginosis

Interventions

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

Sponsors & Collaborators

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Ragon Institute of MGH, MIT and Harvard

  collaborator OTHER

• Centre for the AIDS Programme of Research in South Africa

  collaborator NETWORK

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Caroline Mitchell, MD, MPH · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-01

Primary Completion

2024-12-26

Completion

2025-02-18

FDA Drug

Yes

Countries

• United States
• South Africa

Study Locations