Impact of Clinician-administered Vaginal Live Biotherapeutic Product
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LC106.
- Who it may be relevant to
- Registry conditions: Bacterial Vaginosis. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, South Africa
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Open-label, Single-arm Study to Assess the Colonization Kinetics of Clinician- Administered Vaginal Live Biotherapeutic Product Containing Multiple Strains of Lactobacillus Crispatus.
Overview
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.
Interventions
- Drug LC106
This is a 6-strain L. crispatus vaginal live biotherapeutic tablet
Primary outcome measures
- Rate of colonization with LBP isolates [Time frame: 5 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
South Africa · 1 center
- CAPRISA — Vulindlela
Identifiers
NCT: NCT07305844 · VMRC-002