NCT07305844

Impact of Clinician-administered Vaginal Live Biotherapeutic Product

Open-label, Single-arm Study to Assess the Colonization Kinetics of Clinician- Administered Vaginal Live Biotherapeutic Product Containing Multiple Strains of Lactobacillus Crispatus.

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 71 (estimated)
• Sponsor: Caroline Mitchell · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm, Phase Ib trial assessing the consistency of response and colonization kinetics of a vaginally inserted live biotherapeutic intervention with optimized adherence.

Detailed description

In this study investigators will enroll participants from the VIBRANT study who received active study product and test the vaginal microbiome. If a participant does not have a Lactobacillus predominant vaginal microbiome, they will re-dose with LC106 in the clinic for three days in a row. This will allow understanding of how consistent the response to LC106 is, and whether directly monitored administration improves results.

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
DRUG	LC106	This is a 6-strain L. crispatus vaginal live biotherapeutic tablet

Timeline

• Start date: 2026-04-22
• Primary completion: 2026-05-30
• Completion: 2026-05-30
• First posted: 2025-12-26
• Last updated: 2026-04-15

Locations

2 sites across 2 countries: United States, South Africa

Regulatory

• FDA-regulated drug study