Analysis of Ameliorative Effects of Oral Probiotics on Bacterial Vaginosis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03116789

Enrollment

Registered

2017-04-17

Start date

2017-04-11

Completion date

2019-12-31

Last updated

2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Vaginosis

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.

Interventions

DIETARY_SUPPLEMENTprobiotics

Two capsules for daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Intervention model description

Randomized, Parallel, open lable Study

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 55 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Nugent Score	4 weeks	The degree of decline for Nugent score

Secondary

Measure	Time frame	Description
Vaginal pH	4 weeks	Vaginal pH value changes
Vaginal secretions microflora	4 weeks	Changes in vaginal secretions microflora

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026