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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Metronidazole + Floragyn® probiotic tablets (Lapi, Indonesia)
Dietary supplementMetronidazole, sold under the brand name Flagyl among others, is an antibiotic and antiprotozoal medication. It is used either alone or with other antibiotics to treat pelvic inflammatory disease, endocarditis, and bacterial vaginosis. It is effective for dracunculiasis, giardiasis, trichomoniasis, and amebiasis. One tablet Floragyn contains Lactobacillus rhamnosus and lactobacillus reuteri, bacteria that are normal flora (good bacteria) of the vagina.
Metronidazole + Cal95
Dietary supplementMetronidazole, sold under the brand name Flagyl among others, is an antibiotic and antiprotozoal medication. It is used either alone or with other antibiotics to treat pelvic inflammatory disease, endocarditis, and bacterial vaginosis. It is effective for dracunculiasis, giardiasis, trichomoniasis, and amebiasis. Cal 95 is a supplement containing multivitamins and minerals including: Calcium, Zinc, Boron and Magnesium. This tablet is used to help meet calcium needs and maintain bone health in menopausal women.
Floragyn® probiotic tablets (Lapi, Indonesia)
Dietary supplementGiven to the control group to ensure the ability of probiotics to maintain a healthy vaginal ecosystem and not the opposite.
Treatment groups
12 Participants
are divided into 3 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Bacterial Vaginosis Status
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.
Time frame
At 0, 1, and 7 weeks duration of trialSecondary outcomes
1
Total Leukocyte Count
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.
Time frame
0 and 7 weeks duration of trial2
Eosinophil Levels
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%.
Time frame
0 and 7 weeks duration of trial3
Monocytes level
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.
Time frame
0 and 7 weeks duration of trial4
Lymphocytes level
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.
Time frame
0 and 7 weeks duration of trialSponsors and contacts
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Source ClinicalTrials.gov