Clinical Research Directory
Browse clinical research sites, groups, and studies.
Probiotic Efficacy in Postmenopausal Women with Bacterial Vaginosis
Sponsor: Hasanuddin University
Summary
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.
Official title: Modulation of Vaginal Microbiota by Lactobacillus Sp As a Probiotic and Immunomodulatory Agent in Postmenopausal Women with Bacterial Vaginosis
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2024-06-26
Completion Date
2024-12-31
Last Updated
2024-10-28
Healthy Volunteers
Yes
Conditions
Interventions
Metronidazole + Floragyn® probiotic tablets (Lapi, Indonesia)
Metronidazole, sold under the brand name Flagyl among others, is an antibiotic and antiprotozoal medication. It is used either alone or with other antibiotics to treat pelvic inflammatory disease, endocarditis, and bacterial vaginosis. It is effective for dracunculiasis, giardiasis, trichomoniasis, and amebiasis. One tablet Floragyn contains Lactobacillus rhamnosus and lactobacillus reuteri, bacteria that are normal flora (good bacteria) of the vagina.
Metronidazole + Cal95
Metronidazole, sold under the brand name Flagyl among others, is an antibiotic and antiprotozoal medication. It is used either alone or with other antibiotics to treat pelvic inflammatory disease, endocarditis, and bacterial vaginosis. It is effective for dracunculiasis, giardiasis, trichomoniasis, and amebiasis. Cal 95 is a supplement containing multivitamins and minerals including: Calcium, Zinc, Boron and Magnesium. This tablet is used to help meet calcium needs and maintain bone health in menopausal women.
Floragyn® probiotic tablets (Lapi, Indonesia)
Given to the control group to ensure the ability of probiotics to maintain a healthy vaginal ecosystem and not the opposite.
Locations (1)
Alfa Farma Health Clinic, Obstetrics and Gynecology Doctor's Practice.
Kendari, South East Sulawesi, Indonesia