ClinicalTrials.gg
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

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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

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03

In context

Vaginosis, Bacterial

240 studies on the registry are indexed under Vaginosis, Bacterial; 39 are open to participants now.

This study's enrollment of 43 is below the median of 100 across 203 interventional studies indexed under Vaginosis, Bacterial.

Browse Vaginosis, Bacterial studies →

Lead sponsor

GenMont Biotech Incorporation is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 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 therapy during this trial.
  • Use of oral or vaginal probiotic products (sachet, capsule, or tablet) four weeks before V1.
  • Participation in another clinical study.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

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

06

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

07

Study locations

1 site
  • KUO general hospital
    Tainan, Minsheng Road, Sec 2, No.22, Taiwan
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2017 to primary completion in Dec 2019, 32 months.

Of 52 interventional studies with no phase under Vaginosis, Bacterial, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 56. This study's 32 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 12, 2017
First posted
Apr 17, 2017
StartActual
Apr 11, 2017
Primary completionActual
Dec 31, 2019
CompletionActual
Dec 31, 2019
Last update
Feb 5, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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 ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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