Probiotic Efficacy in Postmenopausal Women with Bacterial Vaginosis

Hasanuddin University

Status: Enrolling

Conditions: Menopause; Bacterial Vaginosis (BV)

Treatments: Dietary Supplement: Metronidazole + Floragyn® probiotic tablets (Lapi, Indonesia); Dietary Supplement: Metronidazole + Cal95; Dietary Supplement: Floragyn® probiotic tablets (Lapi, Indonesia)

Study type: Interventional

Funder types: Other

Identifiers

NCT06659380

B3/UN4.6.4.5.31-1/ PP36 / 2024

Details and patient eligibility

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.

Full description

Postmenopausal women experience hormonal changes, particularly in estrogen and progesterone levels. The reduction or even cessation of estrogen secretion in postmenopausal women leads to an increased dominance of pathogenic bacteria in the vagina, which during the premenopausal period was inhibited by Lactobacillus sp. The presence of Lactobacillus in the vaginal epithelium acts as a barrier against external pathogens and produces metabolic byproducts that are unfavorable for the growth of other bacteria. The availability of glycogen, which is influenced by estrogen levels, supports the presence of Lactobacillus as an energy source. This association explains why women entering menopause are at increased risk of developing bacterial vaginosis. In addition, it is known that female reproductive hormones regulate both innate and adaptive immune responses and modulate endocrine functions that influence Th1 and Th2 cytokines, suppress excessive inflammation, and restore homeostasis.

This study conduct to investigate the effects of probiotic therapy on the vaginal microbiota changes in menopausal women and its impact on immunological profiles. Administering Lactobacillus sp. probiotics is expected to modulate bacterial growth disrupted during perimenopause and help restore homeostasis.

All postmenopausal women, during sample collected period, who meet the inclusion criteria will be enrolled as research subjects. Initially, vaginal swabs and venous blood samples will be collected to assess the bacterial vaginosis condition and hematological profiles. Once bacterial vaginosis is diagnosed, subjects will receive standard antibiotic therapy, metronidazole oral 400-500 mg twice daily or 0,75% metronidazole gel 5 grams intravaginally once daily for 5 days. 48 hours after antibiotic administration, participants will be randomly divided into two groups: the treatment group, receiving Floragyn® probiotics, and the placebo group, receiving Cal95®. Probiotic or placebo treatment will be administered orally once daily for two weeks. A healthy control group will also be included for comparison and will receive Floragyn® for two weeks.

Four weeks after the last probiotic dose, vaginal swabs and venous blood samples will be collected. The analysis will include pH, glucose, protein levels, and microbiome composition from the vaginal swabs, while venous blood samples will be analyzed for interleukin 6 and 10 levels, as well as inflammatory markers such as platelets, leukocytes, and differential leukocyte counts. The collected data will be analyzed to evaluate microbiome alterations and inflammatory markers in the treatment and placebo groups.

Enrollment: 12 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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12 participants in 3 patient groups, including a placebo group

Intervention

Experimental group

Description:

This group consist of postmenopausal women diagnosed with bacterial vaginosis. All subjects will receive metronidazole oral 400-500 mg twice daily or 0,75% metronidazole gel 5 grams intravaginally once daily for 5 days, then blind-randomly including to the treatment group and will receive Floragyn® probiotic tablets (Lapi, Indonesia) orally once daily for two weeks.

Treatment:

Dietary Supplement: Metronidazole + Floragyn® probiotic tablets (Lapi, Indonesia)

Placebo

Placebo Comparator group

Description:

This group consist of postmenopausal women diagnosed with bacterial vaginosis. All subjects will receive metronidazole oral 400-500 mg twice daily or 0,75% metronidazole gel 5 grams intravaginally once daily for 5 days, then blind-randomly including to the placebo group and will receive Cal95® probiotic tablets (Lapi, Indonesia) orally once daily for two weeks.

Treatment:

Dietary Supplement: Metronidazole + Cal95

Control

Active Comparator group

Description:

This group consist of postmenopausal women with no bacterial vaginosis. All subjects will receive Floragyn® probiotic tablets (Lapi, Indonesia) orally once daily for two weeks.

Treatment:

Dietary Supplement: Floragyn® probiotic tablets (Lapi, Indonesia)