Analysis of Ameliorative Effects of Oral Probiotics on Bacterial Vaginosis
NCT ID: NCT03116789
Last Updated: 2020-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
43 participants
INTERVENTIONAL
2017-04-11
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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VGA-1(Probiotics)
Lactobacillus rhamnosus and Lactobacillus acidophilus.
probiotics
Two capsules for daily
VGA-2(Probiotics)
Lactobacillus rhamnosus and Lactobacillus plantarum.
probiotics
Two capsules for daily
Interventions
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probiotics
Two capsules for daily
Eligibility Criteria
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Inclusion Criteria
* Subjects with bacterial vaginosis and Nugent score as 4-10
* Subjects in age of 20-55 years old
* Regularly menstruating premenopausal women (normal menstrual function (Eumenorrhoea) shall mean regular menstrual bleeding pattern every 28 plus/minus 10 days)
* Forbidden sexual behavior was required 72 hours before all visits
Exclusion Criteria
* Allergy to test products (raw material components included: Anhydrous glucose, Magnesium stearate, Fructooligosaccharides, Microcrystalline cellulose, Lactobacillus, etc.)
* Bleeding from genital tract of unknown aetiology.
* Congenital and acquired immunodeficiencies.
* Diabetes
* Mental illness
* Malignant tumor
* Application of NuvaRing hormonal contraceptive vaginal ring
* Application of mechanical contraceptives, such as: diaphragms, intrauterine contraceptive insert, except condom
* Application of hormonal preparations, such as: Vagifem, Ovestin and vaginal estrogens in reproductive period.
* Mycotic vaginitis
* Antibiotic(unless indicated by PI) and steroids therapy during this trial.
* Use of oral or vaginal probiotic products (sachet, capsule, or tablet) four weeks before V1.
* Participation in another clinical study.
20 Years
55 Years
FEMALE
No
Sponsors
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Kuo General Hospital
OTHER
GenMont Biotech Incorporation
INDUSTRY
Responsible Party
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Principal Investigators
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Ta-Chin Lin
Role: PRINCIPAL_INVESTIGATOR
Kuo General Hospital
Locations
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KUO general hospital
Tainan City, , Taiwan
Countries
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Other Identifiers
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NP105004
Identifier Type: -
Identifier Source: org_study_id
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