Bacterial VaginosisPhase 4NCT03894813
Probiotics as Adjuvant Treatment for Bacterial Vaginosis
A Phase 4 study testing "Probiotics" and "Metronidazole" and Metronidazole Vaginal in people with Bacterial Vaginosis, run by Peking University Shenzhen Hospital at 1 site in China.
Trial summary
The investigators are trying to determine if oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (30 days)with metronidazole vaginal suppositories(7 days) is better than using metronidazole vaginal suppositories only in preventing the recurrence of bacterial vaginosis (BV). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- "Probiotics" and "Metronidazole" and Metronidazole Vaginal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2019to 30 Dec 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 65 years old, with history of sexual activity, premenopausal women；
- Nugent Score ≥ 7 for diagnosing BV；
- Sign informed consent.
Who cannot join
- mixed vaginitis, such as vulvovaginal candidiasis (VVC), Trichomonas vaginalis (TV) infection, Chlamydia trachomatis (CT) infection or gonococcal vaginitis;
- History of systemic organic diseases or psychiatric diseases;
- Planning for or during pregnancy, lactation, menstruation;
- within 5 days of onset of the disease, any antibiotics has been used;
- Long-term use of contraceptives or immunosuppressant;
- Anaphylactic constitution or allergic to known ingredients of research drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital
The investigators are trying to determine if oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (30 days)with metronidazole vaginal suppositories(7 days) is better than using metronidazole vaginal suppositories only in preventing the recurrence of bacterial vaginosis (BV).
Read the detailed description
Studies have shown that oral probiotics can significantly promote the recovery of vaginal flora mainly because intestinal microbiota can migrate and affect vaginal microecology. This project aims to evaluate the efficacy of oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (30 days) with metronidazole vaginal suppositories(7 days) in the treatment of bacterial vaginosis and to explore the correlation between vaginal flora and fecal flora by detecting the metagenomics of vaginal secretions and intestinal feces at the time of baseline phase, the first month after treatment, the third month after treatment and the sixth month after treatment.
- Conditions
- Bacterial Vaginosis
- Being tested
- "Probiotics" and "Metronidazole", Metronidazole Vaginal
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Probiotics" and "Metronidazole"Drug
Also called Umeta-Miyue, Lactobacillus rhamnosus GR-1 & Lactobacillus reuteri RC-14 and Metronidazole Suppositories
Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days)
Metronidazole VaginalDrug
Also called Metronidazole Suppositories
Metronidazole Suppositories,qd, 7 days
| Study group | Role | What they receive |
|---|---|---|
| Probiotics and Metronidazole | Experimental | Probiotics: Oral probiotics(Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) ) (qd, 30 days); Metronidazole: Metronidazole vaginal suppositories (qd,7 days) Receives: Drug: "Probiotics" and "Metronidazole" |
| Metronidazole vaginal | Active comparator | Metronidazole vaginal suppositories(1 suppositories,qd,7 days ) Receives: Drug: Metronidazole Vaginal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Related Clinical Signs or Symptoms at Baseline
Clinical signs and symptoms of bacteria vaginosis (BV), including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at baseline, the number of participants with related clinical signs or symptoms at Baseline were calculated.
Measured: 1 day before starting treatment
Number of Participants With Clinically Effective in Each Study Arm in the 30-day Follow-up
Clinical signs and symptoms of BV, including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at the 30-day, the number of participants with clinically effective (with the sign or symptoms disappeared or released compared with the baseline data) were calculated.
Measured: the 30th day after starting treatment
Number of Participants With Clinically Effective in Each Study Arm at the 90-day Follow-up
Clinical signs and symptoms of BV, including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at the 30-day, the number of participants with clinically effective (with the sign or symptoms disappeared or released compared with the 30-day follow-up data) were calculated.
Measured: the 90th day after starting treatment
Number of Participants With Bacteriological Cure in Each Study Arm at the 30-day Follow-up
A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score can range from 0 to 10. Bacteriological cure of BV was defined as a normal Nugent score of 0-6. Participants who were clinical failures, or had a Nugent score ≥ 7 were therapeutic failures.
Measured: the 30th day after starting treatment
Number of Participants With Bacteriological Cure in Each Study Arm at the 90-day Follow-up
A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score can range from 0 to 10. Bacteriological cure of BV was defined as a normal Nugent score of 0-6. Participants who were clinical failures, or had a Nugent score ≥ 7 were therapeutic failures.
Measured: the 90th day after starting treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start26 Mar 2019
- 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.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Shenzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- BGI, China
- Responsible party
- Principal investigator, Shangrong Fan, Peking University Shenzhen Hospital
- Investigators
- Ruifang Wu, M.D., Study director, Dept of Obstetrics and Gynecology,Peking University Shenzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894813
- Sponsor's protocol ID
- PUshenzhenH2018-016
- Status last verified
- Jun 2021
- First submitted
- 14 Mar 2019
- Last updated
- 9 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital
- ClinicalTrials.gov ID
- NCT03894813
- Acronym / sponsor ID
- PUshenzhenH2018-016
- Conditions
- Bacterial Vaginosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Peking University Shenzhen HospitalUniversity, hospital or other
- Collaborators
- BGI, China
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 29 Mar 2019 (actual)
- Results
- Posted 9 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are trying to determine if oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (30 days)with metronidazole vaginal suppositories(7 days) is better than using metronidazole vaginal suppositories only in preventing the recurrence of bacterial vaginosis (BV).
Detailed description
Studies have shown that oral probiotics can significantly promote the recovery of vaginal flora mainly because intestinal microbiota can migrate and affect vaginal microecology. This project aims to evaluate the efficacy of oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (30 days) with metronidazole vaginal suppositories(7 days) in the treatment of bacterial vaginosis and to explore the correlation between vaginal flora and fecal flora by detecting the metagenomics of vaginal secretions and intestinal feces at the time of baseline phase, the first month after treatment, the third month after treatment and the sixth month after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics and Metronidazole | Experimental | Drug: "Probiotics" and "Metronidazole"Probiotics: Oral probiotics(Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) ) (qd, 30 days); Metronidazole: Metronidazole vaginal suppositories (qd,7 days) |
| Metronidazole vaginal | Active comparator | Drug: Metronidazole VaginalMetronidazole vaginal suppositories(1 suppositories,qd,7 days ) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 to 65 years old, with history of sexual activity, premenopausal women；
- Nugent Score ≥ 7 for diagnosing BV；
- Sign informed consent.
Key exclusion criteria (6 listed)
- mixed vaginitis, such as vulvovaginal candidiasis (VVC), Trichomonas vaginalis (TV) infection, Chlamydia trachomatis (CT) infection or gonococcal vaginitis;
- History of systemic organic diseases or psychiatric diseases;
- Planning for or during pregnancy, lactation, menstruation;
- within 5 days of onset of the disease, any antibiotics has been used;
- Long-term use of contraceptives or immunosuppressant;
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 |
|---|---|---|
| "Probiotics" and "Metronidazole"Also: Umeta-Miyue, Lactobacillus rhamnosus GR-1 & Lactobacillus reuteri RC-14 and Metronidazole SuppositoriesOral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days) | Drug | Probiotics and Metronidazole |
| Metronidazole VaginalAlso: Metronidazole SuppositoriesMetronidazole Suppositories,qd, 7 days | Drug | Metronidazole vaginal |
Primary outcome
Number of Participants With Related Clinical Signs or Symptoms at Baseline
Time frame: 1 day before starting treatment
Clinical signs and symptoms of bacteria vaginosis (BV), including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at baseline, the number of participants with related clinical signs or symptoms at Baseline were calculated.
Number of Participants With Clinically Effective in Each Study Arm in the 30-day Follow-up
Time frame: the 30th day after starting treatment
Clinical signs and symptoms of BV, including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at the 30-day, the number of participants with clinically effective (with the sign or symptoms disappeared or released compared with the baseline data) were calculated.
Number of Participants With Clinically Effective in Each Study Arm at the 90-day Follow-up
Time frame: the 90th day after starting treatment
Clinical signs and symptoms of BV, including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at the 30-day, the number of participants with clinically effective (with the sign or symptoms disappeared or released compared with the 30-day follow-up data) were calculated.
Number of Participants With Bacteriological Cure in Each Study Arm at the 30-day Follow-up
Time frame: the 30th day after starting treatment
A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score can range from 0 to 10. Bacteriological cure of BV was defined as a normal Nugent score of 0-6. Participants who were clinical failures, or had a Nugent score ≥ 7 were therapeutic failures.
Number of Participants With Bacteriological Cure in Each Study Arm at the 90-day Follow-up
Time frame: the 90th day after starting treatment
A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score can range from 0 to 10. Bacteriological cure of BV was defined as a normal Nugent score of 0-6. Participants who were clinical failures, or had a Nugent score ≥ 7 were therapeutic failures.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ruifang Wu, M.D. study director
Dept of Obstetrics and Gynecology,Peking University Shenzhen Hospital
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 "Probiotics" and "Metronidazole" and Metronidazole Vaginal in people with Bacterial Vaginosis, 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 3 inclusion and 6 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 9 Jul 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?
Yes. Results are posted in the registry (first posted 9 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Related Clinical Signs or Symptoms at Baseline (time frame: 1 day before starting treatment). The study lists 5 primary outcomes in all. 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 9 Jul 2021.