Status:
COMPLETED
Effects of LiveSpo X-SECRET in SupportiveTreatment of Vaginitis
Lead Sponsor:
Anabio R&D
Collaborating Sponsors:
Hanoi Obstetrics and Gynecology Hospital
Centers for Disease Control and Prevention
Conditions:
Vaginitis
Eligibility:
FEMALE
18-60 years
Phase:
NA
Brief 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...
Detailed Description
Vaginitis is a disease related to women's reproductive tract including bacterial vaginosis (Bacterial vaginosis - BV), sexually transmitted diseases (Sexually Transmitted Diseases - STDs)... This is c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06165354
Start Date
December 1 2023
End Date
June 30 2025
Last Update
July 25 2025
Active Locations (2)
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1
Centers for Disease Control and Prevention
Bắc Ninh, Bac Ninh, Vietnam, 220000
2
Hanoi Obstetrics and Gynecology Hospital
Ba Dinh, Hanoi, Vietnam, 100000