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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
160
Phase 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.
Phase 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)
Time frame: Day 6 to Day 180
Analysis of BV recurrences diagnosed using Nugent score (≥ 7) (main secondary endpoint)
Compared to Placebo
Time frame: Day 6 to Day 180
Analysis of BV recurrences diagnosed using both Amsel criteria (≥ 3 of 4 positive) and Nugent score (≥7)
Compared to placebo
Time frame: Day 6 to Day 180
Time to first BV recurrence as per Amsel's criteria (≥3 of 4 positive) and/or Nugent Score (≥7)
Compared to Placebo
Time frame: Day 6 to Day 180
Proportion of participants experiencing 2 or more, and 3 or more BV infections during the study period.
Compared to Placebo
Time frame: Day 6 to Day 180
Percentage of patients receiving first-line or second-line SOC and duration (days).
Compared to Placebo
Time frame: Day 6 to Day 180
Absolute difference in the duration of the SOC consumption (days).
Compared to Placebo
Time frame: Day 6 to Day 180
Reducing the duration and severity of symptoms (itching, vaginal discharge, and odor) assessed by Visual Analogue Scale (VAS).
Compared to Placebo
Time frame: Day 0, Day 6, Day 22, Day 90, Day 180, and at recurrence visits (if patients have a BV recurrence during the study time frame, they will ask for a "recurrence visit" to assess medication and some study parameters).
Percentage of patients with recovery of normal Nugent score (0-3).
Compared to Placebo
Time frame: Day 6 to Day 22
Vaginal health by International Consultation on Incontinence Questionnaire - Vaginal symptoms (ICIQ-VS).
Compared to Placebo
Time frame: Day 0, Day 6, Day 22, Day 90 and Day 180
Change in vaginal pH assessed by vaginal pH strip method.
Compared to Placebo
Time frame: Day 0, Day 6, Day 22, Day 90, Day 180, and at recurrence visits (if patients have a BV recurrence during the study time frame, they will ask for a "recurrence visit" to assess medication and some study parameters).
Concentration of proinflammatory cytokines.
Compared to Placebo
Time frame: Day 0, Day 22
Relative abundances of lactobacilli and common pathogens associated to BV assessed by using Next-Generation Sequencing (NGS).
Compared to Placebo
Time frame: Day 0, Day 6, Day 22, Day 90, Day 180
Percentage of women with vaginal Community State Types (CSTs) associated to healthy vaginal microbiota.
Compared to Placebo
Time frame: Day 0, Day 6, Day 22, Day 90, Day 180
Analysis of BV recurrences (including intermediate BV) as confirmed per Amsel criteria (≥ 3 of 4 positive) and Nugent score (score≥4) throughout the 6-month period.
Compared to Placebo
Time frame: Day 6 to Day 180
Analysis of BV recurrences (including intermediate BV) as confirmed per Nugent score (score ≥4) throughout the 6-month period.
Compared to Placebo
Time frame: Day 6 to Day 180
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