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Clinical Trials/NCT07305844
NCT07305844CompletedPhase 1

Open-label, Single-arm Study to Assess the Colonization Kinetics of Clinician- Administered Vaginal Live Biotherapeutic Product Containing Multiple Strains of Lactobacillus Crispatus.

Caroline Mitchell · Massachusetts General Hospital2 sites in 2 countries26 enrolledStarted: April 28, 2026Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
26
Locations
2
Primary Endpoint
Rate of colonization with LBP isolates
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
N/A
Intervention Model
Single group
Primary Purpose
Treatment
Masking
None (open label)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts 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

Arms & Interventions

Re-challenge

Experimental

Administration of LC106 in clinic, for three days

Intervention: LC106 (Drug)

Outcomes

Primary Outcomes

Rate of colonization with LBP isolates

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Caroline MitchellMassachusetts General Hospital
Sponsor Class
Other
Responsible Party
Sponsor-investigator
Principal Investigator

Caroline Mitchell

Associate Professor

Massachusetts General Hospital

Study Sites (2)

Loading locations...

Identifiers

NCT ID
NCT07305844
Other Study IDs
VMRC-002

Dates

First Submitted
(9 months ago)
First Posted
(9 months ago)
Primary Completion
(last month)
Study Completion
(last month)
Last Verified
(29 days ago)
Last updated
(yesterday)

Regulatory & Sharing

FDA Regulated Drug
Yes
FDA Regulated Device
No
IPD Sharing Plan
Yes

Microbial sequences

Has Results
No

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