Impact of Clinician-administered Vaginal Live Biotherapeutic Product

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Caroline Mitchell
Study ID
NCT07305844
Phase
EARLY_PHASE1
Status
Enrolling By Invitation

Conditions

  • Bacterial Vaginosis

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • LC106 — DRUG
    This is a 6-strain L. crispatus vaginal live biotherapeutic tablet

Study Details

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.

Key Dates

Start date
Apr 28, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
71 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Re-challenge
    Administration of LC106 in clinic, for three days

Primary Outcome Measure

Rate of colonization with LBP isolates [ Time Frame: 5 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MA

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