About this trial
This study is a double-blind, randomized, controlled trial (RCT) aimed at evaluating the effects of Lactobacillus sp. probiotic administration on the vaginal microbiota changes in postmenopausal women with bacterial vaginosis and how its affect to immunology profile. Postmenopausal women diagnosed with bacterial vaginosis will be recruited as subjects as long as collected period in this study. All patients will receive Metronidazole antibiotic treatment then blind-randomly be divided into two groups: the treatment group, receiving Floragyn® probiotic tablets (Lapi, Indonesia), and the placebo group, receiving Cal 95® (Lapi, Indonesia). As a control, postmenopausal women without bacterial vaginosis will also be included and receive Floragyn® probiotic tablets only.
Eligibility criteria
Qualifiers
Postmenopausal with estradiol levels < 25 mg/ml
Diagnosed have bacterial vaginosis by an obstetrician and gynecologist
Disqualifiers
Medically unable to perform a pap smear examination
Experiencing vaginal bleeding of unknown cause
Diagnosed or suspected of having a malignant disease
Hypersensitivity to the research treatment to be carried out
Trial design
Treatments tested in this trial
- Metronidazole + Floragyn® probiotic tablets (Lapi, Indonesia)
- Metronidazole + Cal95
- Floragyn® probiotic tablets (Lapi, Indonesia)