Probiotic Efficacy in Postmenopausal Women with Bacterial Vaginosis

Not Applicable

Recruiting

• Conditions: Bacterial Vaginosis (BV); Menopause

• Registration Number: NCT06659380
• Lead Sponsor: Hasanuddin University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2024-06-26
• Status Verified: 2024-10
• Study First Submitted: 2024-10-23
• Study First Submitted QC: 2024-10-24
• Last Update Submitted: 2024-10-24
• Study First Posted: 2024-10-26
• Last Update Posted: 2024-10-28
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bacterial Vaginosis Status	At 0, 1, and 7 weeks duration of trial	A health status of woman reproduction diagnosed by nugent score. Nugent score calculations are carried out by looking at bacterial morphology ie Lactobacillus (parallel - sided, gram positive rods), Mobilincus (curved - Gram negative rods), and Gardnerella / Bacteriodes (tiny, gram-variable cocobacilli and rounded, pleomorphic, gram-negative rods with vacuoles). Score 0-3 is normal flora, score 4-6 is intermediate, score 7-10 is bacterial vaginosis.

Secondary Outcome Measures

Name	Time	Method
Total Leukocyte Count	0 and 7 weeks duration of trial	Leukocytes function to detect and fight microorganisms or foreign pathogens that can cause disease, such as viruses, fungi, bacteria, and parasites. Increased levels in the body can be a sign of an ongoing inflammatory process. Leukocyte levels in this study were taken using venous blood samples. its level is expressed in units of 10\^3/uL and normal values are 4-10 10\^3/uL.
Eosinophil Levels	0 and 7 weeks duration of trial	Eosinophils are white blood cells that have a primary function in fighting infections and responding to various types of allergens in the body. Eosinophil levels that exceed the normal range should be watched out for because they can indicate an inflammatory disease. Calculation of eosinophil levels is done using venous blood samples. Eosinophil levels are expressed in % units and normal values are 2-4%.
Monocytes level	0 and 7 weeks duration of trial	This type of white blood cell functions to capture and fight attacks by fungi, bacteria, viruses, or parasites that enter the body. The normal level of monocytes is around 2-8% of the total number of white blood cells in the body. The sample used for measurement is venous blood.
Lymphocytes level	0 and 7 weeks duration of trial	Lymphocytes are white blood cells that play an important role in protecting the body from various infectious diseases. In addition, the level of lymphocytes in the body can also be a sign of certain medical conditions such as infection and inflammation. The normal level of monocytes is around 20-40% of the total number of white blood cells in the body. The sample used for measurement is venous blood.
Interleukin-6 level	0 and 7 weeks duration of trial	Interleukin-6 is a cytokine secreted from body tissues into blood plasma, especially in acute or chronic infection phases, and induces an inflammatory response. The sample used to assess interleukin 6 levels is venous blood with a normal value of interleukin 6 in the blood being \<4 pg/ml.
Interleukin-10 level	0 and 7 weeks duration of trial	Interleukin-10 is a cytokine abundantly secreted by monocytes, which has pleiotropic effects on the immune system and inflammation by inhibiting the activation and effector functions of T cells, monocytes and macrophages. The sample used to assess interleukin 10 levels is venous blood with a normal value of interleukin 10 in the blood being \<18 pg/ml.

Trial Locations

Locations (1)

Alfa Farma Health Clinic, Obstetrics and Gynecology Doctor's Practice.; 🇮🇩 Kendari, South East Sulawesi, Indonesia