Effects of LiveSpo X-SECRET in SupportiveTreatment of Vaginitis
Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
Vaginitis is a common reproductive infection in women worldwide, particularly in tropical and
underdeveloped countries. Traditional antibiotic treatments can disrupt the balance of
beneficial bacteria, requiring repeated use, seriously affecting women's health. Therefore,
probiotics are microorganisms that are beneficial to human health when consumed in sufficient
amounts, playing an important role in maintaining the balance of the body's microflora,
especially in the intestines and vagina. Many studies around the world have proven that
probiotic strains belonging to the genera Lactobacillus, Bifidobacterium, Bacillus, and
Saccharomyces can help reduce the incidence and severity of bacterial vaginal infections and
yeast infections. However, the effectiveness of oral or tablet probiotics is limited due to a
slow onset of action and sensitivity to acidic conditions and temperature. In this study, the
investigators proposed that vaginal spray probiotics containing Bacillus strains combined
with proven stability in both acidic and thermal environments, may be a safe and effective
symptomatic treatment for vaginal infections due to pathogenic bacteria, viruses, fungi,
and/or flagellates. This probiotic supportive therapy may offer a promising alternative to
traditional antibiotic therapy by (i) inhibiting the growth of pathogenic microorganism; (ii)
regulating pro-inflammatory cytokines; and (iii) improving vaginal microbiota.
The aim of the study is to evaluate the effectiveness of vaginal-spraying Bacillus probiotics
in LiveSpo®️ X-SECRET (5 billion CFU/5 mL B. subtilis, B. clausii, and B. coagulans) in
preventing and supporting the treatment of vaginal infections.
Study Population: The study is being carried out at Hanoi Obstetrics and Gynecology Hospital
(Hanoi OGH) and Bac Ninh Center for Disease Control and Prevention (Bac Ninh CDC). The sample
size is 120 per each location.
Description of Study Intervention: In each location, a total of 120 eligible patients are
recruited and divided randomly into 2 groups (n = 60/group/location): Control and
Experimental groups. Patients in the Control group received routine treatment and 2-3
times/day 0.9% NaCl physiological saline while patients in the experimental group were
treated with LiveSpo X-SECRET 2-3 times/day in addition to the same standard of care
treatment. While the standard treatment regimen lasts for 7 days, the probiotic treatment is
continually maintained for 28 days.
Study duration: 8 months.
Phase:
N/A
Details
Lead Sponsor:
Anabio R&D
Collaborators:
Centers for Disease Control and Prevention Hanoi Obstetrics and Gynecology Hospital