Probiotic treatment for bacterial vaginosis in postmenopausal women
Modulation of Vaginal Microbiota by Lactobacillus Sp As a Probiotic and Immunomodulatory Agent in Postmenopausal Women with Bacterial Vaginosis
This study is testing whether taking probiotics after antibiotic treatment can help restore healthy vaginal bacteria in postmenopausal women with bacterial vaginosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Sex | Female |
| Sponsor | Hasanuddin University Academic / other |
| Locations | 1 site (Kendari, South East Sulawesi) |
| Trial ID | NCT06659380 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of Lactobacillus sp. probiotics on vaginal microbiota and immunological profiles in postmenopausal women diagnosed with bacterial vaginosis. Participants will first receive Metronidazole antibiotic treatment and then be randomly assigned to either a treatment group receiving probiotics or a placebo group. The study aims to understand how probiotic therapy can restore the balance of vaginal bacteria disrupted during menopause. Additionally, a control group of postmenopausal women without bacterial vaginosis will also be included to assess the effects of probiotics.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women with estradiol levels below 25 mg/ml and a diagnosis of bacterial vaginosis.
Not a fit: Patients with acute infectious diseases of the genital organs or those who have received hormone therapy in the last three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel treatment option for postmenopausal women suffering from bacterial vaginosis.
How similar studies have performed: While the use of probiotics in treating bacterial vaginosis has been explored, this specific approach in postmenopausal women is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Kendari, South East Sulawesi
- Alfa Farma Health Clinic, Obstetrics and Gynecology Doctor's Practice. — Kendari, South East Sulawesi, Indonesia (Recruiting)
Study contacts
- Study coordinator: Yenti Purnamasari
- Email: yenti.purnamasari@gmail.com
- Phone: +628114058258
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.