Effects of LiveSpo X-SECRET in SupportiveTreatment of Vaginitis

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anabio R&D
• Collaborators: Centers for Disease Control and Prevention; Hanoi Obstetrics and Gynecology Hospital

Criteria

Inclusion Criteria:

• Women from 18 to 60 years old

• Diagnosed with vaginitis with obvious symptoms and manifestations such as:

vulvar/vaginal ulcers, inflammation, vaginal odor, vaginal itching, vaginal cololr, painful/ painful urination, lower abdominal pain; pain during sex; abnormal vaginal bleeding…

• Positive for one of the following pathogents that cause vaginitis, such as Gardnerella vaginalis, Mycoplasma hominis, Candida albicans, Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, HSV-1, HSV-2, Trichomonas vaginalis, detected by real-time PCR assay.

• The patient agrees to participate in the study, explains and signs the consent form to participate in the study.

Exclusion Criteria:

• Women who are pregnant or breast-feeding, have diabetes, are using antibiotics/anti-inflammatory drugs in the vaginal area within the previous 14 days

• Vaginal bleeding of unknown cause or cancer

• Have a history of drug allergy and hypersensitivity to any ingredient in probiotics or placebo

• Leave the study before day 7

• Simultaneous participation in another clinical trial or use of probiotics for the gynecological tract within the past 14 days

• Meets criteria for mental, cognitive, depressive or anxiety disorders

• Do not agree to participate in the study