Analysis of Ameliorative Effects of Oral Probiotics on Bacterial Vaginosis

Not Applicable

Completed

• Conditions: Bacterial Vaginosis
• Interventions: Dietary Supplement: probiotics

• Registration Number: NCT03116789
• Lead Sponsor: GenMont Biotech Incorporation

Brief Summary

The purpose of this study is to analyze the ameliorative effects of oral probiotics on bacterial vaginosis.

Detailed Description

To analyze the oral Lactobacillus rhamnosus with Lactobacillus acidophilus or Lactobacillus rhamnosus with Lactobacillus plantarum could be ameliorative effects for bacterial vaginosis.

Study Timeline

• Study Start: 2017-04-11
• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-12
• Study First Posted: 2017-04-17
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VGA-2(Probiotics)	probiotics	Lactobacillus rhamnosus and Lactobacillus plantarum.
VGA-1(Probiotics)	probiotics	Lactobacillus rhamnosus and Lactobacillus acidophilus.

Primary Outcome Measures

Name	Time	Method
Nugent Score	4 weeks	The degree of decline for Nugent score

Secondary Outcome Measures

Name	Time	Method
Vaginal secretions microflora	4 weeks	Changes in vaginal secretions microflora
Vaginal pH	4 weeks	Vaginal pH value changes

Trial Locations

Locations (1)

KUO general hospital; 🇨🇳 Tainan, Taiwan