Vaginal Live Biotherapeutic for Bacterial Vaginosis

Not yet recruiting at 1 trial location

Overseen By Disebo Potloane, MD

Age: 18 - 65

Sex: Female

Trial Phase: Phase < 1

Sponsor: Caroline Mitchell

Must not be taking: Antibiotics, Probiotics

Disqualifiers: Infection requiring antibiotics, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

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

Are You a Good Fit for This Trial?

Inclusion Criteria

Previous participant in the VIBRANT study, randomized to active LBP

Nugent score 4-10

Exclusion Criteria

I have used an oral or vaginal probiotic in the last 30 days.

Infection requiring antibiotics detected on screening labs

I have not taken any antibiotics by mouth or vaginally in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LC106 in the clinic for three consecutive days

1 week

3 visits (in-person)

Follow-up

Participants are monitored for colonization and response consistency

5 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LC106

How Is the Trial Designed?

Group I: Re-challenge Experimental Treatment 1 Intervention

Administration of LC106 in clinic, for three days

Who Is Running the Clinical Trial?

Caroline Mitchell

Lead Sponsor