NCT03116789

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 12, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 17, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

2.7 years

First QC Date

April 12, 2017

Last Update Submit

February 3, 2020

Conditions

Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

  • Nugent Score

    The degree of decline for Nugent score

    4 weeks

Secondary Outcomes (2)

  • Vaginal pH

    4 weeks

  • Vaginal secretions microflora

    4 weeks

Study Arms (2)

VGA-1(Probiotics)

ACTIVE COMPARATOR

Lactobacillus rhamnosus and Lactobacillus acidophilus.

Dietary Supplement: probiotics

VGA-2(Probiotics)

ACTIVE COMPARATOR

Lactobacillus rhamnosus and Lactobacillus plantarum.

Dietary Supplement: probiotics

Interventions

probioticsDIETARY_SUPPLEMENT

Two capsules for daily

VGA-1(Probiotics)VGA-2(Probiotics)

Eligibility Criteria

Age20 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KUO general hospital

Tainan, Minsheng Road, Sec 2, No.22, Taiwan

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Ta-Chin Lin

    Kuo General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized, Parallel, open lable Study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2017

First Posted

April 17, 2017

Study Start

April 11, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 5, 2020

Record last verified: 2020-02

Locations

TW(1)