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Bacterial VaginosisEarly Phase 1VIBRANTNCT06135974

Vaginal lIve Biotherapeutic RANdomized Trial

A Early Phase 1 study testing LC106, LC115 and Metronidazole Oral in people with Bacterial Vaginosis, run by Massachusetts General Hospital at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this randomized clinical trial is to evaluate safety and biologic effect of a multi-strain vaginal L. crispatus live biotherapeutic product (LBP) in people receiving antibiotic treatment for bacterial vaginosis (BV). Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Bacterial Vaginosis
What is being tested?
LC106, LC115 and Metronidazole Oral
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
2 sitesin 2 countries
Study dates
1 Feb 2024to 18 Feb 2025
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Premenopausal individuals, 18- 40 years old
  • BV by Amsel criteria (at least 3 of 4 criteria must be present)
  • Abnormal Nugent score: ≥ 7
  • Willing and able to provide written informed consent.
  • HIV uninfected (by HIV Ab/Ag test at enrollment)
  • Not pregnant by pregnancy test at enrollment, and unlikely to have an early pregnancy per clinician's assessment of last menstrual period and recent sexual activity.
  • On continuous oral contraceptives (US site) or injectable progestin contraceptives (South African site) that suppress menstrual cycles, or willing to suppress menstrual cycles with one of these types of hormonal contraceptives
  • Willing and able to attend study visits and comply with study procedures

Who cannot join

  • History of clinically significant vaginal, cervical, or uterine disease including but not limited to: cancer of the female reproductive tract
  • Prior hysterectomy
  • 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.
  • Use of antibiotics in the past 30 days
  • Syphilis (positive screen at enrollment)
  • Vulvovaginal candidiasis (positive microscopy at enrollment)
Show all 23Show fewer
  • Allergy to or contraindication to use of oral metronidazole
  • High grade abnormal Pap (HSIL, AGC [Atypical Glandular Cells], ASCUS-H) at enrollment (LSIL, ASCUS, or HPV+ are all non-exclusionary)
  • Currently participating in another study of an investigational product (excluding COVID vaccine studies)
  • Use of long-acting systemic investigational product (e.g. injectable PrEP) within the past year
  • Subject taking any of the following medications currently or in the past 30 days: systemic steroids (inhaled or nasal steroid therapy is permitted), interleukins, systemic interferons (e.g. local injection of interferon alpha for treatment of human papillomavirus is permitted) or systemic chemotherapy.
  • 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.
  • Use of an IUD (intrauterine device)
  • Use of probiotics, prebiotics or synbiotics (supplements and products, oral or vaginal) within past 30 days. (NOTE: Oral yogurt with live cultures is allowed, as are fermented foods.)
  • Active COVID-19 infection (determined by a positive PCR test of a nasal or nasopharyngeal swab) or recent exposure (< 14 days) to someone with confirmed COVID-19 infection (an exposure is considered being within 6 feet/180 cm of someone without a mask for more than 15 minutes). Potential participants who meet these criteria can delay screening until they have completed isolation or quarantine.
  • Vaginal cleansing practices in the past 30 days (i.e. vaginal products for cleaning or drying, vaginal douching) (by eligibility questionnaire)
  • Any other condition or situation that in the opinion of the investigator will compromise ability to participate in the study.
  • Menopause: surgical; or absence of periods not due to hormonal contraception and in the setting of prior chemotherapy
  • Use of testosterone for any reason
  • Systolic blood pressure > 180 or diastolic blood pressure > 110 at screening or enrollment
  • Hemoglobin < 9
  • Less than 2 weeks since 2nd COVID vaccination (mRNA) or 1st vaccination (J\&J) or booster
  • Either breastfeeding/lactating or pregnant within 8 weeks prior to study entry

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

South Africa1 site

  • CAPRISA - Vulindlela

    Msunduzi Municipality, KwaZulu-Natal

Other trials in South Africa

About this study

Official title: Phase 1 Trial of Multi-strain Lactobacillus Crispatus Vaginal Live Biotherapeutic Product

The goal of this randomized clinical trial is to evaluate safety and biologic effect of a multi-strain vaginal L. crispatus live biotherapeutic product (LBP) in people receiving antibiotic treatment for bacterial vaginosis (BV). The main question[s] it aims to answer are whether the intervention is safe, and whether the strains of L. crispatus will colonize recipients' vagina. The study will evaluate one LBP with 6 strains of L. crispatus (LC106) and one LBP with 15 strains (LC115) vs. placebo.

Participants will:

Read more
  • be treated with oral antibiotics for BV
  • receive 7 days of vaginal study product
  • collect daily home swabs and make short daily diary entries for 5 weeks, including the week of antibiotic treatment and the week of study product treatment.

Researchers will compare the 3 groups receiving different dosing strategies of LC106 and 1 group receiving LC115 vs. 1 group receiving placebo to see if the live biotherapeutic strains colonize the vagina after antibiotic treatment for BV.

Read the detailed description

This is a Phase I randomized trial of a novel live biotherapeutic intervention containing multiple strains of L. crispatus.

  1. crispatus is a species of Lactobacillus commonly found in the human vagina, which is associated with optimal reproductive health outcomes. Detection of, and dominance of the community by, L. crispatus is associated with lower risk for bacterial vaginosis (BV), but no intervention to date has demonstrated the ability to durably shift the vaginal microbiome to L. crispatus dominance in a majority of treated people.

In this study, we will compare safety and biologic effects of two formulations of a consortia of L. crispatus strains, and a variety of dosing strategies in women with BV who receive antibiotic treatment. Our primary outcome is colonization with any of the L. crispatus strains contained in the live biotherapeutic product. All participants will have menses suppressed with either injectable progesterone contraception or continuous oral contraceptive pills for the duration of the study.

All participants will receive 7 days of oral metronidazole (500mg twice daily) and will be randomized to one of five groups:

  1. Placebo daily for 7d after metronidazole treatment
  2. LC-106 daily for 7d after metronidazole treatment
  3. LC-106 daily for 3d + 4 days of placebo, starting after metronidazole treatment
  4. LC-106 daily for 7d, starting on day 3 of metronidazole treatment
  5. LC-115 daily for 7d after metronidazole treatment
Being tested
LC106, LC115, Placebo, Metronidazole Oral
Keywords
live biotherapeutic, bacterial vaginosis, vaginitis
Medical subject headings
Vaginosis, Bacterial, Vaginitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LC106Drug

    Tablet containing at least 2 x 10^6 CFU/tablet, and comprised of 6 strains of Lactobacillus crispatus

  • LC115Drug

    Tablet containing at least 2 x 10^6 CFU/tablet, and comprised of 15 strains of Lactobacillus crispatus

  • PlaceboDrug

    Vaginal tablets containing primarily microcrystalline cellulose and no live bacteria

  • Metronidazole OralDrug

    Metronidazole tablet orally twice daily for 7 days

Study groups in NCT06135974
Study groupRoleWhat they receive
PlaceboPlacebo comparatorVaginal placebo tablet administered daily for 7 days starting after antibiotic treatment
Receives: Drug: Placebo; Drug: Metronidazole Oral
LC106 7 daysExperimentalVaginal live biotherapeutic product with 6 strains of L. crispatus, administered daily for 7 days after antibiotic treatment
Receives: Drug: LC106; Drug: Metronidazole Oral
LC106 3 daysExperimentalVaginal 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)
Receives: Drug: LC106; Drug: Metronidazole Oral
LC106 7 days, early startExperimentalVaginal live biotherapeutic product with 6 strains of L. crispatus, administered daily for 7 days starting on the 3rd day of antibiotic treatment
Receives: Drug: LC106; Drug: Metronidazole Oral
LC115ExperimentalVaginal live biotherapeutic product with 15 strains of L. crispatus, administered daily for 7 days after antibiotic treatment
Receives: Drug: LC115; Drug: Metronidazole Oral

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Detection of LBP strains by metagenomic sequencing

    Detection of any one strain from the LBP at 5% relative abundance or greater, or any combination of strains at 10% relative abundance or greater using shotgun metagenomic sequencing

    Measured: Over 5 weeks

  2. Adverse events

    Assessment of safety by comparing number and severity of adverse events

    Measured: Over 12 weeks

Secondary outcomes (5)

  1. Kinetics of colonization

    Presence and quantity of each strain contained in the LBP measured by strain-specific quantitative PCR

    Measured: Over 12 weeks

  2. Recurrent BV by Amsel and Nugent criteria

    Presence of BV by Amsel criteria and/or Nugent criteria

    Measured: Over 12 weeks

  3. Non-iners Lactobacillus dominance and abundance

    Using 16S rRNA sequencing, relative abundance of non-iners Lactobacillus species in the vaginal fluid, and proportion with dominance by these species (> 50% relative abundance)

    Measured: Over 12 weeks

  4. Alpha and beta diversity of the microbial community

    Comparison of alpha and beta diversity metrics between arms before and after treatment with LBP

    Measured: Over 12 weeks

  5. Proportion of participants reporting product was acceptable to use

    Participant perceptions of and preferences for the vaginal LBP treatment

    Measured: Over 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start1 Feb 2024
  3. Primary completion26 Dec 2024
  4. Study completion18 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a randomized trial with 5 arms
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06135974
Sponsor's protocol ID
VMRC001
Acronym
VIBRANT
Status last verified
Mar 2025
First submitted
2 Nov 2023
Last updated
25 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual participant data may be made available once primary and secondary analyses are completed, to investigators who request it.

Publications

  • Milford C, Dlamini BL, Mafunda NA, Hardwick TS, Lewis L, Khan AA, Mdladla MN, Mitchell CM, Potloane D. Bacterial Vaginosis [BV] knowledge, attitudes and behavioural changes after BV diagnosis among women enrolled in a clinical trial in Boston, USA and Vulindlela, South Africa: a qualitative study. BMC Womens Health. 2025 Dec 12;26(1):32. doi: 10.1186/s12905-025-04210-3.

    PubMed 41382078

  • Chetty C, Mafunda N, Happel AU, Khan A, Cooley Demidkina B, Yende-Zuma N, Saidi Y, Mahabeer Polliah A, Lewis L, Osman F, Radebe P, Passmore JS, Kwon D, Ravel J, Ngcapu S, Liebenberg L, Symul L, Holmes S, Mitchell CM, Potloane D. Randomized trial of multi-strain Lactobacillus crispatus vaginal live biotherapeutic products after antibiotic therapy for bacterial vaginosis: study protocol for VIBRANT (vaginal lIve biotherapeutic RANdomized trial). Contemp Clin Trials Commun. 2025 Sep 16;48:101554. doi: 10.1016/j.conctc.2025.101554. eCollection 2025 Dec.

    PubMed 41050878

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing LC106, LC115 and Metronidazole Oral in people with Bacterial Vaginosis, run by Massachusetts General Hospital at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Detection of LBP strains by metagenomic sequencing (time frame: Over 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06135974, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.

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