NCT06135974 - Vaginal lIve Biotherapeutic RANdomized Trial | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 1, 2024

Primary Completion Date

December 26, 2024

Study Completion Date

February 18, 2025

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

Trial Locations (2)

Massachusetts General Hospital, Boston

CAPRISA - Vulindlela, Msunduzi Municipality

All Listed Sponsors

collaborator

Bill and Melinda Gates Foundation

OTHER

collaborator

Ragon Institute of MGH, MIT and Harvard

OTHER

collaborator

Centre for the AIDS Programme of Research in South Africa

NETWORK

lead

Massachusetts General Hospital

OTHER