Actively Recruiting
Probiotic Efficacy in Postmenopausal Women with Bacterial Vaginosis
Led by Hasanuddin University · Updated on 2024-10-28
12
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Probiotic Efficacy in Postmenopausal Women with Bacterial Vaginosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Postmenopausal women with estradiol levels below 25 mg/ml
- Diagnosed with bacterial vaginosis by an obstetrician and gynecologist
You will not qualify if you...
- Unable to perform a pap smear examination
- Experiencing vaginal bleeding of unknown cause
- Diagnosed or suspected of having malignant disease
- Hypersensitivity to the study treatments
- Received hormone therapy within the last 3 months
- Suffering from acute infectious diseases of the genital organs
- Using any form of vaginal therapy
- Suffering from systemic diseases
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Alfa Farma Health Clinic, Obstetrics and Gynecology Doctor's Practice.
Kendari, South East Sulawesi, Indonesia, 93117
Actively Recruiting
Research Team
Y
Yenti Purnamasari
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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