Bacterial VaginosisNCT03116789
Analysis of Ameliorative Effects of Oral Probiotics on Bacterial Vaginosis
A study testing probiotics in people with Bacterial Vaginosis, run by GenMont Biotech Incorporation at 1 site in Taiwan.
Trial summary
The purpose of this study is to analyze the ameliorative effects of oral probiotics on bacterial vaginosis. Read more about this study
- Who is it for?
- Ages 20 to 55 years, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Apr 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Bacterial Vaginosis
- Being tested
- probiotics
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probioticsDietary supplement
Two capsules for daily
| Study group | Role | What they receive |
|---|---|---|
| VGA-1(Probiotics) | Active comparator | Lactobacillus rhamnosus and Lactobacillus acidophilus. Receives: Dietary Supplement: probiotics |
| VGA-2(Probiotics) | Active comparator | Lactobacillus rhamnosus and Lactobacillus plantarum. Receives: Dietary Supplement: probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nugent Score
The degree of decline for Nugent score
Measured: 4 weeks
Secondary outcomes (2)
Vaginal pH
Vaginal pH value changes
Measured: 4 weeks
Vaginal secretions microflora
Changes in vaginal secretions microflora
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start11 Apr 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Parallel, open lable Study
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- GenMont Biotech Incorporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kuo General Hospital
- Responsible party
- Sponsor
- Investigators
- Ta-Chin Lin, Principal investigator, Kuo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116789
- Sponsor's protocol ID
- NP105004
- Status last verified
- Feb 2020
- First submitted
- 12 Apr 2017
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Ameliorative Effects of Oral Probiotics on Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT03116789
- Acronym / sponsor ID
- NP105004
- Conditions
- Bacterial Vaginosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- GenMont Biotech IncorporationIndustry (pharma, biotech, devices)
- Collaborators
- Kuo General Hospital
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 17 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, Parallel, open lable Study
| Arm | Type | Receives |
|---|---|---|
| VGA-1(Probiotics) | Active comparator | Dietary Supplement: probioticsLactobacillus rhamnosus and Lactobacillus acidophilus. |
| VGA-2(Probiotics) | Active comparator | Dietary Supplement: probioticsLactobacillus rhamnosus and Lactobacillus plantarum. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probioticsTwo capsules for daily | Dietary supplement | VGA-1(Probiotics), VGA-2(Probiotics) |
Primary outcome
Nugent Score
Time frame: 4 weeks
The degree of decline for Nugent score
2 secondary outcomes
Vaginal pH
Time frame: 4 weeks
Vaginal secretions microflora
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Bacterial Vaginosis
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ta-Chin Lin principal investigator
Kuo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotics in people with Bacterial Vaginosis, run by GenMont Biotech Incorporation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nugent Score (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.