Effects of LiveSpo X-secret in Supporting Treatment of Sexually Transmitted Diseases

Summary

Sexually Transmitted Infections (STIs) are common gynecological infections worldwide, especially in tropical and underdeveloped countries, primarily affecting the reproductive age group. Microbial pathogens causing STIs include bacteria, viruses, fungi, and protozoa. In Vietnam, STIs are a significant public health concern due to their high incidence and tendency to have mild or no symptoms, making them easy to overlook. While antibiotics or antifungal drugs are typically used to treat STIs caused by bacterial or fungal agents such as Chlamydia, Gonorrhea, and Candida, no specific treatment exists for most viral STIs. Thus, vaccination and symptomatic treatment are the primary methods of prevention. The use of broad-spectrum antibiotics can result in side effects such as loss of appetite, fatigue, and sexual problems, while repeated treatments can lead to the emergence of antibiotic resistance, posing a significant challenge for STI treatment worldwide. However, the efficacy of oral or suppository-based probiotics is limited by their slow onset and sensitivity to acidic and temperature conditions. Fortunately, Bacillus strains of probiotics have demonstrated exceptional stability in both acidic and temperature environments, making them particularly well-suited for use as vaginal spray probiotics against STIs. Here, investigators propose that vaginal-spraying probiotics containing Bacillus strains could be a safe and effective symptomatic treatment for STIs caused by viral, fungi, or bacterial pathogens, providing a promising alternative to traditional antibiotic therapy.

The aim of the study about to evaluate the effectiveness of vaginal-spraying probiotics containing spores of three strains of Bacillus subtilis, Bacillus clausii, and Bacillus coagulans in preventing and supporting the treatment of vaginal infections.

Study Population: sample size is 100. The study is being carried out at Bac Ninh Center for Disease Control.

Description of Study Intervention: total of 100 eligible patients are divided randomly into 2 groups (n = 50/group): Patients in the Control group received routine treatment and 3 times/day 0.9% NaCl physiological saline while the patients in the experimental group were treated with LiveSpo X-secret 3 times/day in addition to the same standard of care treatment. The standard treatment regimen is 7 days and is maintained for 28 days.

Study duration: 36 months

Conditions

• Sexually Transmitted Diseases

Interventions

COMBINATION_PRODUCT

LiveSpo X-secret

In Vietnam, LiveSpo X-secret is manufactured as a Class-A medical device product (Product declaration No.220003286/PCBA-HN) under manufacturing standards approved by Hanoi Health Department, Ministry of Health, Vietnam (Certificate No YT117-19) and ISO 13485:2016.

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 15 mL-bottle that is used for LiveSpo X-secret.

Sponsors & Collaborators

• Hanoi University of Science

  collaborator OTHER

• Anabio R&D

  lead INDUSTRY

Principal Investigators

• Ha TV Bui, PhD. · VNU University of Sciences, Viet Nam National University

• Anh TV Nguyen, PhD. · Spobio Research Center, ANABIO R&D Ltd., Hanoi, Vietnam

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

2020-05-03

Primary Completion

2023-03-31

Completion

2023-03-31

Countries

• Vietnam

Study Locations