Bacterial Vaginosis
Conditions
Brief 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.
Interventions
DRUGLC106
This is a 6-strain L. crispatus vaginal live biotherapeutic tablet
Sponsors
Caroline Mitchell
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of colonization with LBP isolates | 5 weeks | Detection of at least one isolate from the LBP with at least 5% relative abundance by metagenomics, or a combination of isolates at 10% or higher. |
Countries
South Africa, United States
Contacts
CONTACTCaroline M Mitchell, MD, MPH
CONTACTDisebo Potloane, MD
PRINCIPAL_INVESTIGATORCaroline M Mitchell, MD, MPH
Massachusetts General Hospital
PRINCIPAL_INVESTIGATORDisebo Potloane, MD
Centre for the AIDS Programme of Research in South Africa
Outcome results
None listed