Bacterial VaginosisPhase 4NCT03099408
Oral Metronidazole With Lactobacillus Vaginal Suppositories to Prevent Recurrence of Bacterial Vaginosis
A Phase 4 study testing Metronidazole Oral and "Metronidazole" and "Lactobacillus" in people with Bacterial Vaginosis and Recurrence, run by Peking University Shenzhen Hospital at 1 site in China.
Trial summary
We are trying to determine if Oral Metronidazole with Lactobacillus Vaginal Suppositories is better than Oral Metronidazole in Preventing the Recurrence of Bacterial Vaginosis Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Bacterial Vaginosis, Recurrence
- What is being tested?
- Metronidazole Oral and "Metronidazole" and "Lactobacillus"
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 30 Dec 2020
- Phase
- Phase 4
- 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 18 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women be at least 18 years of age
- Have symptoms of vaginal odor and or/discharge
- Meet the clinical (Amsel) criteria for BV
- Willing to participate in research
Who cannot join
- Presence of another vaginal infection or STD
- Allergy to metronidazole
- Pregnant or nursing
- Use of oral or intravaginal antibiotics within the past 2 weeks
- HIV or other chronic disease
- Inability to keep return appointments
- Contraindications for Lactobacillus Vaginal Suppositories（those without sexual history）
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Efficacy and Safety of Oral Metronidazole Versus Oral Metronidazole With Lactobacillus Vaginal Suppositories to Prevent the Recurrence of Bacterial Vaginosis
We are trying to determine if Oral Metronidazole with Lactobacillus Vaginal Suppositories is better than Oral Metronidazole in Preventing the Recurrence of Bacterial Vaginosis
Read the detailed description
Bacterial vaginosis (BV) is the most prevalent cause of symptomatic vaginal discharge in the U.S. and has been associated with complications including preterm delivery of infants, pelvic inflammatory disease (PID), urinary tract infections (UTI) and acquisition/transmission of sexually transmitted diseases (STDs) including human immunodeficiency virus (HIV).
Control of BV has been advocated as a means of decreasing the prevalence of these complications. However, the etiology of BV remains unknown and the current treatment regimens are inadequate in terms of initial cure and recurrence rates.
Based on currently national guidelines by using oral metronidazole 400 BID for 7 days, a high recurrence rate of BV were reported.
We hypothesize that the Oral Metronidazole with Lactobacillus Vaginal Suppositories is better than Oral Metronidazole in Preventing the Recurrence of Bacterial Vaginosis
- Conditions
- Bacterial Vaginosis, Recurrence
- Being tested
- Metronidazole Oral, "Metronidazole" and "Lactobacillus"
- Keywords
- Recurrence, Lactobacillus Vaginal Suppositories
- Medical subject headings
- Vaginosis, Bacterial, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronidazole OralDrug
Oral metronidazole 400 mg BID for 7 days at first month.
"Metronidazole" and "Lactobacillus"Drug
Oral metronidazole metronidazole 400 mg BID for 7 days at first month and Lactobacillus vaginal suppositories for 10 days at first month,second month and third month.
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole Oral | Active comparator | Metronidazole Oral Receives: Drug: Metronidazole Oral |
| "Metronidazole" and "Lactobacillus" | Active comparator | "Metronidazole" and "Lactobacillus" Receives: Drug: "Metronidazole" and "Lactobacillus" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate of BV
Nugent score
Measured: 4 weeks
Secondary outcomes (2)
Recurrence of BV
Nugent score
Measured: 12 weeks
Recurrence of BV
Nugent score
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 Jul 2017
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Shenzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shangrong Fan, Peking University Shenzhen Hospital
- Investigators
- Shangrong Fan, M.D., Principal investigator, Peking University Shenzhen HospitalSalvatore Giovanni Vitale, M.D., Principal investigator, Department of Human Pathology in Adulthood and Childhood, University of Messina (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099408
- Sponsor's protocol ID
- 2016PUSZH001
- Status last verified
- Jan 2021
- First submitted
- 28 Mar 2017
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Efficacy and Safety of Oral Metronidazole Versus Oral Metronidazole With Lactobacillus Vaginal Suppositories to Prevent the Recurrence of Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT03099408
- Acronym / sponsor ID
- 2016PUSZH001
- Conditions
- Bacterial Vaginosis, Recurrence
- Keywords
- Recurrence, Lactobacillus Vaginal Suppositories
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Peking University Shenzhen HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 4 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.
We are trying to determine if Oral Metronidazole with Lactobacillus Vaginal Suppositories is better than Oral Metronidazole in Preventing the Recurrence of Bacterial Vaginosis
Detailed description
Bacterial vaginosis (BV) is the most prevalent cause of symptomatic vaginal discharge in the U.S. and has been associated with complications including preterm delivery of infants, pelvic inflammatory disease (PID), urinary tract infections (UTI) and acquisition/transmission of sexually transmitted diseases (STDs) including human immunodeficiency virus (HIV).
Control of BV has been advocated as a means of decreasing the prevalence of these complications. However, the etiology of BV remains unknown and the current treatment regimens are inadequate in terms of initial cure and recurrence rates.
Based on currently national guidelines by using oral metronidazole 400 BID for 7 days, a high recurrence rate of BV were reported.
We hypothesize that the Oral Metronidazole with Lactobacillus Vaginal Suppositories is better than Oral Metronidazole in Preventing the Recurrence of Bacterial Vaginosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metronidazole Oral | Active comparator | Drug: Metronidazole OralMetronidazole Oral |
| "Metronidazole" and "Lactobacillus" | Active comparator | Drug: "Metronidazole" and "Lactobacillus""Metronidazole" and "Lactobacillus" |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women be at least 18 years of age
- Have symptoms of vaginal odor and or/discharge
- Meet the clinical (Amsel) criteria for BV
- Willing to participate in research
Key exclusion criteria (7 listed)
- Presence of another vaginal infection or STD
- Allergy to metronidazole
- Pregnant or nursing
- Use of oral or intravaginal antibiotics within the past 2 weeks
- HIV or other chronic disease
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 |
|---|---|---|
| Metronidazole OralOral metronidazole 400 mg BID for 7 days at first month. | Drug | Metronidazole Oral |
| "Metronidazole" and "Lactobacillus"Oral metronidazole metronidazole 400 mg BID for 7 days at first month and Lactobacillus vaginal suppositories for 10 days at first month,second month and third month. | Drug | "Metronidazole" and "Lactobacillus" |
Primary outcome
Cure rate of BV
Time frame: 4 weeks
Nugent score
2 secondary outcomes
Recurrence of BV
Time frame: 12 weeks
Recurrence of BV
Time frame: 24 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 1 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Bacterial Vaginosis
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WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
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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.
Shangrong Fan, M.D. principal investigator
Peking University Shenzhen Hospital
Salvatore Giovanni Vitale, M.D. principal investigator
Department of Human Pathology in Adulthood and Childhood, University of Messina (Italy)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metronidazole Oral and "Metronidazole" and "Lactobacillus" in people with Bacterial Vaginosis and Recurrence, run by Peking University Shenzhen Hospital at 1 site in China.
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 4 inclusion and 7 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 1 Feb 2021. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cure rate of BV (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 1 Feb 2021.