Bacterial VaginosisEarly Phase 1NCT07305844
Impact of Clinician-administered Vaginal Live Biotherapeutic Product
A Early Phase 1 study testing LC106 in people with Bacterial Vaginosis, run by Caroline Mitchell at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- LC106
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 Apr 2026to 13 Aug 2026
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Previous participant in the VIBRANT study, randomized to active LBP
- Nugent score 4-10
Who cannot join
- 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 locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
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.
Read the 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
- Being tested
- LC106
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LC106Drug
This is a 6-strain L. crispatus vaginal live biotherapeutic tablet
| Study group | Role | What they receive |
|---|---|---|
| Re-challenge | Experimental | Administration of LC106 in clinic, for three days Receives: Drug: LC106 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of colonization with LBP isolates
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.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start28 Apr 2026
- Primary completion13 Aug 2026
- Study completion13 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caroline Mitchell
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Caroline Mitchell, Massachusetts General Hospital
- Investigators
- Caroline M Mitchell, MD, MPH, Principal investigator, Massachusetts General HospitalDisebo Potloane, MD, Principal investigator, Centre for the AIDS Programme of Research in South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305844
- Sponsor's protocol ID
- VMRC-002
- Status last verified
- Sep 2026
- First submitted
- 12 Dec 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Microbial sequences