Live Biotherapeutic Product for Bacterial Vaginosis (VIBRANT Trial)

Palo Alto (17 mi)

Overseen byCaroline Mitchell, MD, MPH

Age: 18 - 65

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Massachusetts General Hospital

Approved in 4 jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I am a premenopausal person aged between 18 and 40.

Exclusion Criteria

I was diagnosed with a cervicovaginal infection, excluding yeast and bacterial vaginosis, within the last 30 days.

I have a yeast infection confirmed by a lab test.

I am allergic to or cannot take oral metronidazole.

I am in menopause due to surgery or because my periods stopped after chemotherapy.

I haven't used any experimental drugs or treatments in the last year.

I am currently using testosterone for a health condition.

I have taken antibiotics in the last 30 days.

I have had a hysterectomy.

I have had significant diseases of the female reproductive organs, including cancer.

Treatment Details

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.

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

Metronidazole Oral is already approved in United States, European Union, India, Canada for the following indications:

🇺🇸 Approved in United States as Flagyl for: