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CompletedNCT03116789Updated Feb 5, 2020

Analysis of Ameliorative Effects of Oral Probiotics on Bacterial Vaginosis

An interventional study of probiotics in Bacterial Vaginosis, sponsored by GenMont Biotech Incorporation. Completed at 1 site in Taiwan. Open to female participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2020-02-05.

Sponsored by GenMont Biotech Incorporation · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
Female
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Bacterial Vaginosis
03

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Active comparator
    VGA-1(Probiotics)

    Lactobacillus rhamnosus and Lactobacillus acidophilus.

    Dietary Supplement: probiotics

  • Active comparator
    VGA-2(Probiotics)

    Lactobacillus rhamnosus and Lactobacillus plantarum.

    Dietary Supplement: probiotics

Interventions

  • Dietary supplementprobiotics

    Two capsules for daily

05

What researchers measure

Primary outcomes

  1. Nugent Score

    The degree of decline for Nugent score

    Time frame: 4 weeks

Secondary outcomes

  1. Vaginal pH

    Vaginal pH value changes

    Time frame: 4 weeks

  2. Vaginal secretions microflora

    Changes in vaginal secretions microflora

    Time frame: 4 weeks

06

Study locations

1 site
  • KUO general hospital
    Tainan, Minsheng Road, Sec 2, No.22, Taiwan
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03116789
Lead sponsor
GenMont Biotech Incorporation
Collaborators
Kuo General Hospital
Responsible party
Sponsor
First posted
Apr 17, 2017
Start date
Apr 11, 2017
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Feb 5, 2020

Study contacts

Ta-Chin Lin
principal investigator · Kuo General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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