Impact of Clinician-administered Vaginal Live Biotherapeu... | NCT07305844

Studies
Impact of Clinician-administered Vaginal Live Biotherapeutic Product

NCT07305844

Sponsor

Caroline Mitchell

Status

Enrolling by invitation

Last Update Posted

May 1, 2026Actual

Enrollment

71Estimated

Phase

Early Phase 1

Conditions

Bacterial Vaginosis

Interventions

LC106

Countries

United States
South Africa

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 28, 2026Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Dec 12, 2025

First Submission Date that Met QC Criteria

Dec 12, 2025

First Posted Date

Dec 26, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2026

Last Update Posted Date

May 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

71Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Re-challenge	Experimental	Administration of LC106 in clinic, for three days	Drug: LC106

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LC106	Drug	This is a 6-strain L. crispatus vaginal live biotherapeutic tablet	Re-challenge

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	5 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Caroline M Mitchell, MD, MPH	Massachusetts General Hospital	Principal Investigator
Disebo Potloane, MD	Centre for the AIDS Programme of Research in South Africa	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States
CAPRISA

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Microbial sequences

Types

Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code

Time Frame

At the time of publication of study results

Access Criteria

THe microbial reads will be posted on a public site, such as the Short Read Archive

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016585	Vaginosis, Bacterial

Ancestor Terms

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D014627	Vaginitis

Browse Leaves

Not provided

Browse Branches

Not provided