NCT07527572

Study to Evaluate Efficacy and Safety of Gyntima® Balance in Preventing Recurrences of Bacterial Vaginosis

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Gyntima® Balance in Preventing Recurrences of Bacterial Vaginosis.

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Kaneka Americas Holding Inc. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Vaginosis, Bacterial
• Bacterial Vaginosis
• Bacterial Vaginosis (BV)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus gasseri KABP®064 10e9 CFU/capsule	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.
DIETARY_SUPPLEMENT	Placebo (maltodextrin)	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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-04-01
• Completion: 2027-10-01
• First posted: 2026-04-14
• Last updated: 2026-04-14