completedNot ApplicableNCT06165354

Effects of LiveSpo X-SECRET in Supportive Treatment of Vaginitis

Sponsor: ANABIO R&D Ltd. Company

AI Summary

First randomised controlled trial demonstrating safety and efficacy of an intravaginal Bacillus spore probiotic spray (LiveSpo X-SECRET) for vaginitis. Results showed 5.7-fold symptom reduction, 275-fold decrease in G. vaginalis, 2.1-fold Lactobacillus increase, and 43–60% reduction in pro-inflammatory cytokines versus saline control.

Trial Details

Condition	vaginitis, bacterial vaginosis
Intervention	LiveSpo X-SECRET intravaginal spray (5 billion CFU/5 mL B. subtilis, B. clausii, B. coagulans), 2–3 times daily for 28 days
Comparator	0.9% normal saline intravaginal spray
Phase	Not Applicable
Status	completed
Participants	240
First Registered	29 May 2025
Lead Investigator	Spobiotic Research Center / ANABIO R&D Ltd. Company

Primary Outcome

Pathogen load reduction (G. vaginalis by qPCR), vaginal microbiome composition (16S rRNA NGS), clinical symptom scores at days 0, 3, 7, 14, 28

Secondary Outcomes

Pro-inflammatory cytokines (IL-1β, IL-8)
Vaginal secretory IgA
Safety and tolerability

Trial Sites

Countries

Vietnam

View Registry Entry

Related Analysis

First Clinical Trial Confirms Safety and Efficacy of Intravaginal Bacillus Spore Probiotic Spray for Vaginitis

A randomised, double-blind trial of LiveSpo X-SECRET—a vaginal spray containing Bacillus subtilis, clausii, and coagulans spores—demonstrated a 5.7-fold reduction in symptoms, 275-fold decrease in G. vaginalis load, and 66% increase in vaginal IgA compared to saline control over 28 days, marking the first demonstrated clinical evidence for intravaginal Bacillus spore probiotics.

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