Trial | NCT03116789  Report issue

Official Title

Analysis of Ameliorative Effects of Oral Probiotics on Bacterial Vaginosis

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    43
The purpose of this study is to analyze the ameliorative effects of oral probiotics on bacterial vaginosis.
To analyze the oral Lactobacillus rhamnosus with Lactobacillus acidophilus or Lactobacillus rhamnosus with Lactobacillus plantarum could be ameliorative effects for bacterial vaginosis.
Study Started
Apr 11
2017
Primary Completion
Dec 31
2019
Study Completion
Dec 31
2019
Last Update
Feb 05
2020

Dietary Supplement probiotics

Two capsules for daily

VGA-1(Probiotics) Active Comparator

Lactobacillus rhamnosus and Lactobacillus acidophilus.

VGA-2(Probiotics) Active Comparator

Lactobacillus rhamnosus and Lactobacillus plantarum.

Criteria 

Inclusion Criteria:

Informed Consent Form.
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:

Subjects are pregnant, lactating or planning to become pregnant.
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.
No Results Posted