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

• Status: Recruiting
• Trial end date: 2023-05-30
• Target enrollment: 0
• Participant gender: Female

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anabio R&D
• Collaborator: Hanoi University of Science

Criteria

Inclusion Criteria:

• Women aged from 18 to 60 years

• Amsel criteria for the diagnosis of vaginitis (presence of 3 of the following four criteria)

• Increased uniform thin vaginal discharge;

• pH of vaginal discharge greater than 4.5;

• Vaginal odor;

• STI positive detected by multiplex real-time PCR TaqMan probe for nine major vaginal pathogens circulating in Vietnam. These include Gardnerella vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma hominis, Mycoplasma genitalium, Human alphaherpesvirus type 1 and 2, Candida albicans, Trichomonas vaginalis;

• Patients agree to participate in the study after a thorough explanation of the research is provided to them, and they sign the research consent form.

Exclusion Criteria:

• Pregnant or nursing women, diabetics, taking antibiotics or antibiotics against vaginal infections in the previous 14 days.

• Unexplained vaginal bleeding or cancer.

• Having a history of drug allergies and hypersensitivity to any ingredient in probiotics or placebo.

• Discharged before day 7

• Meeting the criteria for psychiatric disorders other than depression and/or anxiety.