Effects of LiveSpo X-secret in Supporting Treatment of Sexually Transmitted Diseases
Status:
Recruiting
Trial end date:
2023-05-30
Target enrollment:
Participant gender:
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