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Probiotic Efficacy in Postmenopausal Women with Bacterial Vaginosis

RecruitingNAAges any - anyFemaleHasanuddin University
NCT06659380 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Postmenopausal with estradiol levels \< 25 mg/ml 2. Diagnosed have bacterial vaginosis by an obstetrician and gynecologist Exclusion Criteria: 1. Medically unable to perform a pap smear examination 2. Experiencing vaginal bleeding of unknown cause 3. Diagnosed or suspected of having a malignant disease 4. Hypersensitivity to the research treatment to be carried out 5. In the last 3 months have received hormone therapy 6. Suffering from acute infectious diseases of the genital organs 7. Using vaginal therapy in any form 8. Suffering from systemic diseases
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What it tests

  • Metronidazole + Floragyn® probiotic tablets (Lapi, Indonesia)
  • Metronidazole + Cal95
  • Floragyn® probiotic tablets (Lapi, Indonesia)
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Where

1 site
Alfa Farma Health Clinic, Obstetrics and Gynecology Doctor's Practice.
Kendari, Indonesia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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