Modulation of Vaginal Microbiota by Lactobacillus Sp As a Probiotic and Immunomodulatory Agent in Postmenopausal Women with Bacterial Vaginosis

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: t
View:

• Postmenopausal with estradiol levels \< 25 mg/ml

• Diagnosed have bacterial vaginosis by an obstetrician and gynecologist

Locations
Other Locations
Indonesia
Alfa Farma Health Clinic, Obstetrics and Gynecology Doctor's Practice.
RECRUITING
Kendari
Contact Information
Primary
Yenti Purnamasari
yenti.purnamasari@gmail.com
+628114058258
Time Frame
Start Date: 2024-06-26
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 12
Treatments
Experimental: Intervention
This group consist of postmenopausal women diagnosed with bacterial vaginosis. All subjects will receive metronidazole oral 400-500 mg twice daily or 0,75% metronidazole gel 5 grams intravaginally once daily for 5 days, then blind-randomly including to the treatment group and will receive Floragyn® probiotic tablets (Lapi, Indonesia) orally once daily for two weeks.
Placebo_comparator: Placebo
This group consist of postmenopausal women diagnosed with bacterial vaginosis. All subjects will receive metronidazole oral 400-500 mg twice daily or 0,75% metronidazole gel 5 grams intravaginally once daily for 5 days, then blind-randomly including to the placebo group and will receive Cal95® probiotic tablets (Lapi, Indonesia) orally once daily for two weeks.
Active_comparator: Control
This group consist of postmenopausal women with no bacterial vaginosis. All subjects will receive Floragyn® probiotic tablets (Lapi, Indonesia) orally once daily for two weeks.
Sponsors
Leads: Hasanuddin University

This content was sourced from clinicaltrials.gov