Probiotic Efficacy in Postmenopausal Women with Bacterial Vaginosis
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Bacterial Vaginosis (BV), Menopause
In brief
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.
Key facts
- Study ID
- NCT06659380
- Run by
- Hasanuddin University
- People needed
- 12
- Starts
- 2024-06-26
- Expected to finish
- 2024-12-31
- Last updated by the study team
- 2024-10-28
Who can join
Age: any. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Postmenopausal with estradiol levels < 25 mg/ml
- Diagnosed have bacterial vaginosis by an obstetrician and gynecologist
You may not qualify if…
- 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
- In the last 3 months have received hormone therapy
- Suffering from acute infectious diseases of the genital organs
- Using vaginal therapy in any form
- Suffering from systemic diseases
Where it is running
- Alfa Farma Health Clinic, Obstetrics and Gynecology Doctor's Practice. — Kendari, South East Sulawesi, Indonesia (enrolling)
Full record on ClinicalTrials.gov
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