Live Biotherapeutic Product for Bacterial Vaginosis

(VIBRANT Trial)

Recruiting at 1 trial location

Overseen By Doug Kwon, MD, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Phase < 1

Sponsor: Massachusetts General Hospital

Must be taking: Oral contraceptives

Must not be taking: Systemic steroids, Interleukins

Disqualifiers: Vaginal disease, Cervicovaginal infection, Syphilis, others

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

24 Participants Needed

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.

Research Team

Caroline Mitchell, MD, MPH

Principal Investigator

Massachusetts General Hospital

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

You are able to and agree to sign a paper saying you understand and agree to be in the study.

You are not pregnant and are not likely to become pregnant based on your last period and recent sexual activity, as determined by a doctor.

You have at least 3 of 4 specific symptoms that indicate a certain condition (BV).

Exclusion Criteria

Syphilis (positive screen at enrollment)

Any other condition or situation that in the opinion of the investigator will compromise ability to participate in the study

History of coronary artery disease, myocardial infarction, chronic obstructive pulmonary disease, chronic renal failure, decompensated cirrhosis, or any other condition that in the opinion of the investigator will compromise ability to participate in the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Antibiotic Treatment

Participants receive 7 days of oral metronidazole (500mg twice daily) for bacterial vaginosis

1 week

1 visit (in-person) for prescription and instructions

Vaginal Biotherapeutic Treatment

Participants receive either placebo or L. crispatus live biotherapeutic product for 7 days, with different dosing strategies

1 week

Daily home swabs and diary entries

Follow-up

Participants are monitored for safety and effectiveness, including adverse events and colonization kinetics

12 weeks

Regular follow-up visits and assessments

Treatment Details

Interventions

• LC106
• LC115
• Metronidazole Oral
• Placebo

Trial Overview 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.

Participant Groups

Group I: LC115 Experimental Treatment 2 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 start Experimental Treatment 2 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 days Experimental Treatment 2 Interventions

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

Group IV: LC106 3 days Experimental Treatment 2 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: Placebo Placebo Group 2 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:

• Pelvic inflammatory disease
• Endocarditis
• Bacterial vaginosis
• Dracunculiasis
• Giardiasis
• Trichomoniasis
• Amebiasis
• Clostridioides difficile colitis

Approved in European Union as Flagyl for:

• Pelvic inflammatory disease
• Endocarditis
• Bacterial vaginosis
• Dracunculiasis
• Giardiasis
• Trichomoniasis
• Amebiasis
• Clostridioides difficile colitis

Approved in India as Metrogyl for:

• Pelvic inflammatory disease
• Endocarditis
• Bacterial vaginosis
• Dracunculiasis
• Giardiasis
• Trichomoniasis
• Amebiasis
• Clostridioides difficile colitis

Approved in Canada as Flagyl for:

• Pelvic inflammatory disease
• Endocarditis
• Bacterial vaginosis
• Dracunculiasis
• Giardiasis
• Trichomoniasis
• Amebiasis
• Clostridioides difficile colitis

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Ragon Institute of MGH, MIT and Harvard

Collaborator

Trials

9

Recruited

1,600+

Bill and Melinda Gates Foundation

Collaborator

Trials

428

Recruited

23,060,000+

Centre for the AIDS Programme of Research in South Africa

Collaborator

Trials

23

Recruited

20,800+