Using probiotics to treat vaginitis

Evaluating the Effectiveness in Supportive Treatment of Vaginitis of Vaginal-spraying Bacillus Probiotic Spore Suspension (LiveSpo X-Secret)

This study is testing a new vaginal spray probiotic to see if it can help women with vaginitis feel better without the side effects of antibiotics.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 60 Years
• Sex: Female
• Sponsor: Anabio R&D (industry)
• Locations: 2 sites (Ba Dinh, Hanoi and 1 other locations)
• Trial ID: NCT06165354 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of LiveSpo X-SECRET, a vaginal spray probiotic containing Bacillus strains, on women diagnosed with vaginitis. The research aims to address the limitations of traditional antibiotic treatments, which can disrupt the natural balance of vaginal bacteria and lead to antibiotic resistance. By utilizing a targeted probiotic approach, the study seeks to improve symptoms associated with vaginitis, such as inflammation and discomfort. Participants will be women aged 18 to 60 who exhibit clear symptoms of vaginitis and test positive for specific pathogens.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 to 60 who have been diagnosed with vaginitis and exhibit specific symptoms.

Not a fit: Patients who are pregnant, breastfeeding, or have certain medical conditions such as diabetes or cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and safer alternative to antibiotics for managing vaginitis.

How similar studies have performed: Previous studies have shown promising results with probiotic treatments for bacterial vaginosis, suggesting potential success for this novel approach.

Eligibility 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

Where this trial is running

Ba Dinh, Hanoi and 1 other locations

• Hanoi Obstetrics and Gynecology Hospital — Ba Dinh, Hanoi, Vietnam (RECRUITING)
• Centers for Disease Control and Prevention — Bac Ninh, Vietnam (RECRUITING)

Study contacts

• Principal investigator: Chuong C Nguyen, MSc. MD — Hanoi Obstetrics and Gynecology Hospital
• Study coordinator: Chuong C Nguyen, MSc. MD

Conditions: Vaginitis, Bacterial vaginosis, Sexually Transmitted Diseases, Vaginal-spraying probiotics, Bacillus spores, Bacteria, Fungi, Virus