search
Back to results

Analysis of Ameliorative Effects of Oral Probiotics on Bacterial Vaginosis

Primary Purpose

Bacterial Vaginosis

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
probiotics
Sponsored by
GenMont Biotech Incorporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bacterial Vaginosis

Eligibility Criteria

20 Years - 55 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • KUO general hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

VGA-1(Probiotics)

VGA-2(Probiotics)

Arm Description

Lactobacillus rhamnosus and Lactobacillus acidophilus.

Lactobacillus rhamnosus and Lactobacillus plantarum.

Outcomes

Primary Outcome Measures

Nugent Score
The degree of decline for Nugent score

Secondary Outcome Measures

Vaginal pH
Vaginal pH value changes
Vaginal secretions microflora
Changes in vaginal secretions microflora

Full Information

First Posted
April 12, 2017
Last Updated
February 3, 2020
Sponsor
GenMont Biotech Incorporation
Collaborators
Kuo General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03116789
Brief Title
Analysis of Ameliorative Effects of Oral Probiotics on Bacterial Vaginosis
Official Title
Analysis of Ameliorative Effects of Oral Probiotics on Bacterial Vaginosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 11, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GenMont Biotech Incorporation
Collaborators
Kuo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Parallel, open lable Study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VGA-1(Probiotics)
Arm Type
Active Comparator
Arm Description
Lactobacillus rhamnosus and Lactobacillus acidophilus.
Arm Title
VGA-2(Probiotics)
Arm Type
Active Comparator
Arm Description
Lactobacillus rhamnosus and Lactobacillus plantarum.
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotics
Intervention Description
Two capsules for daily
Primary Outcome Measure Information:
Title
Nugent Score
Description
The degree of decline for Nugent score
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Vaginal pH
Description
Vaginal pH value changes
Time Frame
4 weeks
Title
Vaginal secretions microflora
Description
Changes in vaginal secretions microflora
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ta-Chin Lin
Organizational Affiliation
Kuo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
KUO general hospital
City
Tainan
ZIP/Postal Code
Minsheng Road, Sec 2, No.22
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Analysis of Ameliorative Effects of Oral Probiotics on Bacterial Vaginosis

We'll reach out to this number within 24 hrs