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

NCT ID: NCT07305844

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-10

Study Completion Date

2026-05-30

Brief Summary

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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

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In this study we will enroll participants from the VIBRANT study who received active study product and test their vaginal microbiome. If they do not have a Lactobacillus predominant vaginal microbiome, we will re-dose with LC106 in the clinic for three days in a row. This will allow us to understand how consistent the response to LC106 is, and whether directly monitored administration improves results.

Conditions

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Bacterial Vaginosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Re-challenge

Administration of LC106 in clinic, for three days

Group Type EXPERIMENTAL

LC106

Intervention Type DRUG

This is a 6-strain L. crispatus vaginal live biotherapeutic tablet

Interventions

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LC106

This is a 6-strain L. crispatus vaginal live biotherapeutic tablet

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Caroline Mitchell

OTHER

Sponsor Role lead

Responsible Party

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Caroline Mitchell

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Caroline M Mitchell, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Disebo Potloane, MD

Role: PRINCIPAL_INVESTIGATOR

Centre for the AIDS Programme of Research in South Africa

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

CAPRISA

Vulindlela, , South Africa

Site Status

Countries

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United States South Africa

Central Contacts

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Caroline M Mitchell, MD, MPH

Role: CONTACT

Phone: 617-724-2182

Email: [email protected]

Disebo Potloane, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Caroline M Mitchell, MD, MPH

Role: primary

Nomfuneko Mafunda, MPH

Role: backup

Disebo Potloane, MD

Role: primary

Callin Chetty

Role: backup

Other Identifiers

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VMRC-002

Identifier Type: -

Identifier Source: org_study_id