Effects of LiveSpo X-SECRET in SupportiveTreatment of Vaginitis

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.

Conditions

• Vaginitis

Interventions

DRUG

0.9% NaCl physiological saline

Vaginal-spraying 0.9% NaCl physiological saline is prepared by extracting 10 mL from 0.9% NaCl intravenous infusion 500 mL PP bottle (B.Braun, Germany, product declaration No. VD-32732-19), and then pouring it into the same opaque metallic spraying 20 mL-bottle.

COMBINATION_PRODUCT

LiveSpo X-secret

In Vietnam, LiveSpo X-SECRET is manufactured as two product lines: (1) Class-A medical device product (Product declaration No.220003286/PCBA-HN) under manufacturing standards approved by Hanoi Department of Health, Ministry of Health, Vietnam and ISO 13485:2016 (Certificate No YT117-19) and (2) comestic (Product declaration No.14981/22/CBMP-HA) under manufacturing standards approved by Hanoi Department of Health, Ministry of Health, Vietnam (Certificate No 118/CNĐĐKSXMP. Both product lines have the same probiotic composition. The cosmetic type was used for the clinical trial conducted at Hanoi OGH. The Class-A medical device type was used for the clinical trial conducted at Bac Ninh CDC.

Sponsors & Collaborators

• Hanoi Obstetrics and Gynecology Hospital

  collaborator OTHER

• Centers for Disease Control and Prevention

  collaborator FED

• Anabio R&D

  lead INDUSTRY

Principal Investigators

• Chuong C Nguyen, MSc. MD · Hanoi Obstetrics and Gynecology Hospital

• Anh TV Nguyen, Assoc. Prof. · Spobio Research Center, Anabio R&D

• Thuy TB Nguyen, MSc. MD · Hanoi Obstetrics and Gynecology Hospital

• Ngoc TB Nguyen, MD · Hanoi Obstetrics and Gynecology Hospital

• Hong T Ngo, MSc · Bac Ninh Center for Disease Control and Prevention

• Huyen T Bui · Spobio Research Center, Anabio R&D

• Hao TN Vo · Spobio Research Center, Anabio R&D

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-01

Primary Completion

2024-12-31

Completion

2025-06-30

Countries

• Vietnam

Study Locations