LC106 for Bacterial Vaginosis
This study is testing a vaginal live biotherapeutic tablet called LC106, which contains six strains of L. crispatus bacteria. It's for women aged 18 to 40 who have bacterial vaginosis (an imbalance of bacteria in the vagina) and previously participated in the VIBRANT study, receiving the active treatment. The main goal is to see how consistently LC106 helps healthy bacteria colonize the vagina. You cannot join if you have an infection needing antibiotics, or have used antibiotics or probiotics recently. The study aims to enroll 71 participants, but its current recruitment status is unclear.
- Study design
- This is an open-label (you and the researchers know what treatment you receive), single-arm (everyone gets the same treatment) study involving about 71 participants.
- What's involved
- If your vaginal microbiome isn't Lactobacillus-predominant, you will receive LC106 in the clinic for three consecutive days.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures colonization with LC106 isolates at 5 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Impact of Clinician-administered Vaginal Live Biotherapeutic Product
At a glance
Conditions
NCT07305844
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
CAPRISA
Vulindlela, South Africano site contact published
Massachusetts General Hospital
Boston, Massachusettsno site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Caroline M Mitchell, MD, MPH · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
- Disebo Potloane, MD · PRINCIPAL_INVESTIGATOR · Centre for the AIDS Programme of Research in South Africa
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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Inclusion
Exclusion
What this trial measures
- Rate of colonization with LBP isolates5 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.