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Antibiotic
Live Biotherapeutic Product for Bacterial Vaginosis (VIBRANT Trial)
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
Must not have
Diagnosed with cervicovaginal infection (inclusive of gonorrhoeae, chlamydia, trichomonas) within the 30 days prior (or at enrollment visit). Yeast and bacterial vaginosis are not exclusionary
Vulvovaginal candidiasis (positive microscopy at enrollment)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 12 weeks
Awards & highlights
Summary
This trial tests whether adding beneficial bacteria called L. crispatus to the vagina can help women with bacterial vaginosis who are taking antibiotics. The goal is to see if these good bacteria can safely and effectively establish themselves in the vagina and maintain a healthy balance. Lactobacillus crispatus has been studied in various clinical trials for its potential to prevent bacterial vaginosis recurrence and restore normal vaginal flora.
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a premenopausal person aged between 18 and 40.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I was diagnosed with a cervicovaginal infection, excluding yeast and bacterial vaginosis, within the last 30 days.
Select...
I have a yeast infection confirmed by a lab test.
Select...
I am allergic to or cannot take oral metronidazole.
Select...
I am in menopause due to surgery or because my periods stopped after chemotherapy.
Select...
I haven't used any experimental drugs or treatments in the last year.
Select...
I am currently using testosterone for a health condition.
Select...
I have taken antibiotics in the last 30 days.
Select...
I have had a hysterectomy.
Select...
I have had significant diseases of the female reproductive organs, including cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ over 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse events
Detection of LBP strains by metagenomic sequencing
Secondary study objectives
Alpha and beta diversity of the microbial community
Kinetics of colonization
Non-iners Lactobacillus dominance and abundance
+2 moreOther study objectives
Comparison of detection of LBP strains by metagenomics between US and South Africa
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Bacterial Vaginosis (BV) include antibiotics like metronidazole and clindamycin, which work by reducing the overgrowth of harmful anaerobic bacteria in the vagina. However, these treatments can also disrupt beneficial bacteria, leading to potential recurrence.
Probiotics, such as the L. crispatus live biotherapeutic product, aim to restore a healthy vaginal microbiome by colonizing the vagina with beneficial bacteria. This helps maintain an acidic environment that inhibits pathogenic bacteria, reducing recurrence risk and promoting long-term vaginal health.
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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
2,999 Previous Clinical Trials
13,231,440 Total Patients Enrolled
Bill and Melinda Gates FoundationOTHER
414 Previous Clinical Trials
22,929,072 Total Patients Enrolled
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