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Antibiotic

Live Biotherapeutic Product for Bacterial Vaginosis (VIBRANT Trial)

Q: Is it possible for me to join this clinical experiment?

To qualify for this clinical trial, potential participants need to be between 18 and 40 years old with a diagnosis of bacterial vaginosis. Approximately 60 individuals are being sought out for the study.

Q: Is the enrollment phase of this clinical trial still open?

According to clinicaltrials.gov, this experiment has been open for recruitment since October 19th 2023 and was last updated on November 13th of the same year.

Q: Does this experiment include minors in its recruitment pool?

As per the parameters for inclusion, only persons between 18 and 40 years old may take part in this trial.

Q: What end-goals are researchers hoping to accomplish with this clinical trial?

This experiment, that will be monitored over a period of 5 weeks, aims to assess adverse events. As secondary objectives it will evaluate the recurrence of Bacterial Vaginosis according to Amsel and Nugent criteria, non-Lactobacillus dominance/abundance in vaginal fluid by way of 16S rRNA sequencing technology and contrast alpha &#x26; beta diversity metrics between arms before and after treatment with LBP.

Q: What is the current enrollment count for this research project?

Affirmative. According to clinicaltrials.gov, this investigation is currently recruiting participants; it was first advertised on October 19th 2023 and recently revised on November 13th 2023. The research requires 60 individuals from 2 distinct study sites.

Phase < 1

Recruiting

Led By Caroline Mitchell, MD, MPH

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Premenopausal individuals, 18-40 years old

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over 12 weeks

Awards & highlights

VIBRANT Trial Summary

This trial is testing if a live biotherapeutic product is safe and effective for bacterial vaginosis after antibiotic treatment. Participants will receive the product and record effects in a diary.

Who is the study for?

This trial is for premenopausal individuals aged 18-40 with bacterial vaginosis, as confirmed by specific criteria. They must be willing to follow the study procedures, not pregnant or breastfeeding, HIV negative, and on certain contraceptives. Exclusions include significant reproductive tract diseases, recent antibiotic use or infections other than BV, certain medication use within the last month, and any condition that may affect participation.Check my eligibility

What is being tested?

The trial tests two vaginal live biotherapeutic products (LBPs) containing different strains of L. crispatus (LC106 & LC115) against a placebo in people treated with antibiotics for BV. It aims to see if these LBPs are safe and can colonize the vagina post-treatment.See study design

What are the potential side effects?

Potential side effects aren't detailed but could include reactions related to introducing live bacteria into the body's system such as local irritation or infection. The safety profile will be closely monitored given it's a new treatment.

VIBRANT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a premenopausal person aged between 18 and 40.

VIBRANT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~over 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and over 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse events

Detection of LBP strains by metagenomic sequencing

Secondary outcome measures

Alpha and beta diversity of the microbial community

Kinetics of colonization

Non-iners Lactobacillus dominance and abundance

+2 more

Other outcome measures

Comparison of detection of LBP strains by metagenomics between US and South Africa

VIBRANT Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: LC115Experimental Treatment2 Interventions

Vaginal live biotherapeutic product with 15 strains of L. crispatus, administered daily for 7 days after antibiotic treatment

Group II: LC106 7 days, early startExperimental Treatment2 Interventions

Vaginal live biotherapeutic product with 6 strains of L. crispatus, administered daily for 7 days starting on the 3rd day of antibiotic treatment

Group III: LC106 7 daysExperimental Treatment2 Interventions

Vaginal live biotherapeutic product with 6 strains of L. crispatus, administered daily for 7 days after antibiotic treatment

Group IV: LC106 3 daysExperimental Treatment2 Interventions

Vaginal live biotherapeutic product with 6 strains of L. crispatus, administered daily for 3 days after antibiotic treatment and packaged with 4 tablets of placebo to maintain masking (so a total of 7 tablets)

Group V: PlaceboPlacebo Group2 Interventions

Vaginal placebo tablet administered daily for 7 days starting after antibiotic treatment

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metronidazole Oral

2019

Completed Phase 4

~190

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ragon Institute of MGH, MIT and HarvardOTHER

8 Previous Clinical Trials

1,606 Total Patients Enrolled

Massachusetts General HospitalLead Sponsor

2,935 Previous Clinical Trials

13,198,581 Total Patients Enrolled

Bill and Melinda Gates FoundationOTHER

407 Previous Clinical Trials

22,924,028 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to join this clinical experiment?

"To qualify for this clinical trial, potential participants need to be between 18 and 40 years old with a diagnosis of bacterial vaginosis. Approximately 60 individuals are being sought out for the study."

Answered by AI

Is the enrollment phase of this clinical trial still open?

"According to clinicaltrials.gov, this experiment has been open for recruitment since October 19th 2023 and was last updated on November 13th of the same year."

Answered by AI

Does this experiment include minors in its recruitment pool?

"As per the parameters for inclusion, only persons between 18 and 40 years old may take part in this trial."

Answered by AI

What end-goals are researchers hoping to accomplish with this clinical trial?

"This experiment, that will be monitored over a period of 5 weeks, aims to assess adverse events. As secondary objectives it will evaluate the recurrence of Bacterial Vaginosis according to Amsel and Nugent criteria, non-Lactobacillus dominance/abundance in vaginal fluid by way of 16S rRNA sequencing technology and contrast alpha & beta diversity metrics between arms before and after treatment with LBP."

Answered by AI

What is the current enrollment count for this research project?

"Affirmative. According to clinicaltrials.gov, this investigation is currently recruiting participants; it was first advertised on October 19th 2023 and recently revised on November 13th 2023. The research requires 60 individuals from 2 distinct study sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vaginal lIve Biotherapeutic RANdomized Trial

Caroline Mitchell 2023. "Vaginal lIve Biotherapeutic RANdomized Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06135974.