The vagina is a dynamic muscular organ whose health relies on a Lactobacillus-dominant microbiota that maintains low pH and protects against infections. Bacterial vaginosis (BV) is the most common vaginal imbalance in women of reproductive age, caused by depletion of protective Lactobacillus species and overgrowth of anaerobic bacteria such as Gardnerella vaginalis. BV affects an estimated 23-29 percentage of women globally (10-30 percentage in India) and is associated with discharge, odor, discomfort, and significant risks including recurrent disease, adverse reproductive outcomes, and increased susceptibility to STIs. Although antibiotics are effective for acute treatment, recurrence rates are high (50-60 percentage within 12 months), highlighting an unmet need for preventive strategies.
Probiotics, particularly Lactobacillus species, have emerged as promising options to restore vaginal microbiota balance and reduce BV recurrence. Lactobacillus gasseri is a natural vaginal commensal with antimicrobial activity against BV pathogens and the ability to lower vaginal pH. L. gasseri KABP®064 has demonstrated vaginal colonization after oral administration, good tolerability, and potential to promote vaginal health.
The present randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of oral L. gasseri KABP®064 in preventing BV recurrence over six months following standard antibiotic therapy. Outcomes include recurrence rates and timing, symptom severity, microbiological balance, inflammation markers, and patient-reported vaginal health, supporting a microbiome-focused, non-antibiotic approach to BV recurrence prevention.
Females of ages 18-45 years (both values included) who are premenopausal.
History of recurrent BV (at least 3 episodes in the last 12 months with at least one of them documented in the last 6 months).
Homogeneous, thin, yellowish-white/greyish white discharge that smoothly coats the vaginal walls.
Presence of the clue cells on microscopic examination (as assessed by wet mount test).
Participants currently taking contraceptives and/or sexual hormones.
Pregnant or breastfeeding.
Menstrual period expected within the next 6 days of screening.
Irregular cycle ("irregular" (e.g., less than 21 or more than 35 days consistently, or cycle variability more than 4 days month-to-month).
Parallel
Lactobacillus gasseri KABP®064 10e9 CFU/capsule
Dietary supplementPhase 1: 15 days, 1 capsule/day post-randomization. Phase 2: 10 days per month for \~6 months, starting 6th day of menstruation, 1 capsule/day.
Placebo (maltodextrin)
Dietary supplementPhase 1: 15 days, 1 capsule/day post-randomization. Phase 2: 10 days per month for \~6 months, starting 6th day of menstruation, 1 capsule/day.
To evaluate the efficacy of Lactobacillus gasseri KABP®064 in preventing recurrence of BV infections, diagnosed using Amsel criteria, over a period of 6 months as compared to placebo.
Amsel criteria (≥3 out of 4 positive)
Analysis of BV recurrences diagnosed using Nugent score (≥ 7) (main secondary endpoint)
Compared to Placebo
Analysis of BV recurrences diagnosed using both Amsel criteria (≥ 3 of 4 positive) and Nugent score (≥7)
Compared to placebo
Time to first BV recurrence as per Amsel's criteria (≥3 of 4 positive) and/or Nugent Score (≥7)
Compared to Placebo
Proportion of participants experiencing 2 or more, and 3 or more BV infections during the study period.
Compared to Placebo
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Kaneka Americas Holding Inc.
Lead sponsor
Vedic Lifesciences Pvt. Ltd.
Collaborator
AB-Biotics
Collaborator
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