Probiotic Efficacy in Postmenopausal Women with Bacterial Vaginosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorHasanuddin University

About this trial

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 criteria

Qualifiers

Postmenopausal with estradiol levels < 25 mg/ml

Diagnosed have bacterial vaginosis by an obstetrician and gynecologist

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

12 Participants
are divided into 3 treatment groups

Sponsors and collaborators