Analysis of Ameliorative Effects of Oral Probiotics on Bacterial Vaginosis

February 3, 2020 updated by: GenMont Biotech Incorporation
The purpose of this study is to analyze the ameliorative effects of oral probiotics on bacterial vaginosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan, Minsheng Road, Sec 2, No.22
        • KUO general hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: VGA-1(Probiotics)
Lactobacillus rhamnosus and Lactobacillus acidophilus.
Dietary supplement: probiotics
Two capsules for daily
Active Comparator: VGA-2(Probiotics)
Lactobacillus rhamnosus and Lactobacillus plantarum.
Dietary supplement: probiotics
Two capsules for daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nugent Score
Time Frame: 4 weeks
The degree of decline for Nugent score
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal pH
Time Frame: 4 weeks
Vaginal pH value changes
4 weeks
Vaginal secretions microflora
Time Frame: 4 weeks
Changes in vaginal secretions microflora
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GenMont Biotech Incorporation

Collaborators

Kuo General Hospital

Investigators

  • Principal Investigator: Ta-Chin Lin, KUO general hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2017

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

April 12, 2017

First Submitted That Met QC Criteria

April 12, 2017

First Posted (Actual)

April 17, 2017

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 3, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP105004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bacterial Vaginosis

Clinical Trials on probiotics

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe