Impact of Clinician-administered Vaginal Live Biotherapeutic Product

Caroline Mitchell

Status and phase: Begins enrollment this month; Early Phase 1

Conditions: Bacterial Vaginosis

Treatments: Drug: LC106

Study type: Interventional

Funder types: Other

Identifiers

NCT07305844

VMRC-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 71 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previous participant in the VIBRANT study, randomized to active LBP
• Nugent score 4-10

Exclusion criteria

• Infection requiring antibiotics detected on screening labs
• Use of oral or vaginal antibiotics in the 30 days prior to screening
• Use of an oral or vaginal probiotic in the 30 days prior to screening

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

71 participants in 1 patient group

Re-challenge

Experimental group

Description:

Administration of LC106 in clinic, for three days

Treatment:

Drug: LC106