Recurrent Bacterial VaginosisPhase 4NCT07893782
Probiotics as an Adjunct to Antibiotics for Recurrent Bacterial Vaginosis
A Phase 4 study testing Probiotic Combination Cap/Tab in people with Recurrent Bacterial Vaginosis, run by Nishtar Medical University at 1 site in Pakistan.
Trial summary
This randomized clinical trial aims to compare the recurrence of bacterial vaginosis (BV) in women receiving probiotics alongside antibiotic treatment versus women receiving antibiotic treatment alone. Bacterial vaginosis is a common vaginal condition that can recur after successful treatment. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Recurrent Bacterial Vaginosis
- What is being tested?
- Probiotic Combination Cap/Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2025to 31 Jan 2026
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Negative urinary pregnancy test
- Recurrent bacterial vaginosis - foul smelling vaginal discharge and vulvar irritation of duration ≤ 2-weeks
Who cannot join
- Diabetes Mellitus
- Immunosuppressive drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Probiotic Adjunctive to Antibiotic in Women With Recurrent Bacterial Vaginosis
This randomized clinical trial aims to compare the recurrence of bacterial vaginosis (BV) in women receiving probiotics alongside antibiotic treatment versus women receiving antibiotic treatment alone. Bacterial vaginosis is a common vaginal condition that can recur after successful treatment.
The main question this study aims to answer is:
Read more
- Does adding probiotics to standard antibiotic treatment reduce the recurrence of bacterial vaginosis compared with antibiotic treatment alone?
The study will include 70 non-pregnant women aged 20-45 years diagnosed with recurrent bacterial vaginosis. All participants will initially receive metronidazole to treat the current episode. After successful treatment is confirmed, participants will be randomly assigned to one of two groups:
- Group A: Probiotic capsules containing Lactobacillus plantarum, Lactobacillus rhamnosus, and Bifidobacterium animalis subsp. lactis, followed by monthly maintenance dosing for four months.
- Group B: Placebo capsules, followed by the same monthly maintenance schedule.
Participants will undergo monthly vaginal examinations for four months to assess whether bacterial vaginosis recurs. Recurrence will be diagnosed using Amsel's criteria, which include assessment of vaginal discharge, vaginal pH, clue cells on microscopy, and a characteristic fishy odor test.
The researchers will compare the frequency of bacterial vaginosis recurrence between the two groups to determine whether adjunctive probiotic treatment reduces recurrence.
- Conditions
- Recurrent Bacterial Vaginosis
- Being tested
- Probiotic Combination Cap/Tab, Placebo capsules
- Keywords
- Bacterial vaginosis, Recurrent bacterial vaginosis, Probiotics, Metronidazole, Lactobacillus plantarum, Lactobacillus rhamnosus, Bifidobacterium animalis subsp. lactis, Vaginal Infection
- Medical subject headings
- Vaginosis, Bacterial, Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Combination Cap/TabDietary supplement
Participants will receive one probiotic capsule (Lactobacillus plantarum PBS067, Lactobacillus rhamnosus LRH020, and Bifidobacterium animalis subsp. lactis BL050) daily for 14 days after successful treatment of bacterial vaginosis. Subsequently, one capsule daily will be taken for 7 days each month, starting on the first day of menstruation, for 4 months.
Placebo capsulesDrug
Participants will receive placebo capsules matching the probiotic capsules in appearance and dosing schedule. One capsule will be taken daily for 14 days after successful treatment of bacterial vaginosis. Followed by one capsule daily for 7 days each month, starting on the first day of menstruation, for 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Adjunctive to Standard Antibiotic Treatment | Experimental | Participants will receive standard antibiotic treatment with oral metronidazole 500 mg twice daily for 7 days to treat bacterial vaginosis. After successful treatment is confirmed according to Amsel's criteria, participants will receive probiotic Receives: Dietary Supplement: Probiotic Combination Cap/Tab |
| Placebo Adjunctive to Standard Antibiotic Treatment | Placebo comparator | Participants will receive standard antibiotic treatment with oral metronidazole 500 mg twice daily for 7 days to treat bacterial vaginosis. After successful treatment is confirmed according to Amsel's criteria, participants will receive placebo Receives: Drug: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of Bacterial Vaginosis
Proportion of participants with recurrent bacterial vaginosis, diagnosed when at least three of the four Amsel criteria are met during follow-up after successful initial treatment.
Measured: From confirmation of initial cure through the 4-month follow-up period, with monthly assessments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start1 Aug 2025
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nishtar Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Komal Saleem, Nishtar Medical University
- Investigators
- Saima A Professor, FCPS, Study chair, Nishtar Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893782
- Sponsor's protocol ID
- U1111-1348-1673
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Probiotic Adjunctive to Antibiotic in Women With Recurrent Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT07893782
- Acronym / sponsor ID
- U1111-1348-1673
- Conditions
- Recurrent Bacterial Vaginosis
- Keywords
- Bacterial vaginosis, Recurrent bacterial vaginosis, Probiotics, Metronidazole, Lactobacillus plantarum, Lactobacillus rhamnosus, Bifidobacterium animalis subsp. lactis, Vaginal Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Nishtar Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 26 Oct 2026 (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.
This randomized clinical trial aims to compare the recurrence of bacterial vaginosis (BV) in women receiving probiotics alongside antibiotic treatment versus women receiving antibiotic treatment alone. Bacterial vaginosis is a common vaginal condition that can recur after successful treatment.
The main question this study aims to answer is:
- Does adding probiotics to standard antibiotic treatment reduce the recurrence of bacterial vaginosis compared with antibiotic treatment alone?
The study will include 70 non-pregnant women aged 20-45 years diagnosed with recurrent bacterial vaginosis. All participants will initially receive metronidazole to treat the current episode. After successful treatment is confirmed, participants will be randomly assigned to one of two groups:
- Group A: Probiotic capsules containing Lactobacillus plantarum, Lactobacillus rhamnosus, and Bifidobacterium animalis subsp. lactis, followed by monthly maintenance dosing for four months.
- Group B: Placebo capsules, followed by the same monthly maintenance schedule.
Participants will undergo monthly vaginal examinations for four months to assess whether bacterial vaginosis recurs. Recurrence will be diagnosed using Amsel's criteria, which include assessment of vaginal discharge, vaginal pH, clue cells on microscopy, and a characteristic fishy odor test.
The researchers will compare the frequency of bacterial vaginosis recurrence between the two groups to determine whether adjunctive probiotic treatment reduces recurrence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Adjunctive to Standard Antibiotic Treatment | Experimental | Dietary Supplement: Probiotic Combination Cap/TabParticipants will receive standard antibiotic treatment with oral metronidazole 500 mg twice daily for 7 days to treat bacterial vaginosis. After successful treatment is confirmed according to Amsel's criteria, participants will receive probiotic |
| Placebo Adjunctive to Standard Antibiotic Treatment | Placebo comparator | Drug: Placebo capsulesParticipants will receive standard antibiotic treatment with oral metronidazole 500 mg twice daily for 7 days to treat bacterial vaginosis. After successful treatment is confirmed according to Amsel's criteria, participants will receive placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Negative urinary pregnancy test
- Recurrent bacterial vaginosis - foul smelling vaginal discharge and vulvar irritation of duration ≤ 2-weeks
Key exclusion criteria (2 listed)
- Diabetes Mellitus
- Immunosuppressive drugs
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 |
|---|---|---|
| Probiotic Combination Cap/TabParticipants will receive one probiotic capsule (Lactobacillus plantarum PBS067, Lactobacillus rhamnosus LRH020, and Bifidobacterium animalis subsp. lactis BL050) daily for 14 days after successful treatment of bacterial vaginosis. Subsequently, one capsule daily will be taken for 7 days each month, starting on the first day of menstruation, for 4 months. | Dietary supplement | Probiotic Adjunctive to Standard Antibiotic Treatment |
| Placebo capsulesParticipants will receive placebo capsules matching the probiotic capsules in appearance and dosing schedule. One capsule will be taken daily for 14 days after successful treatment of bacterial vaginosis. Followed by one capsule daily for 7 days each month, starting on the first day of menstruation, for 4 months. | Drug | Placebo Adjunctive to Standard Antibiotic Treatment |
Primary outcome
Recurrence of Bacterial Vaginosis
Time frame: From confirmation of initial cure through the 4-month follow-up period, with monthly assessments.
Proportion of participants with recurrent bacterial vaginosis, diagnosed when at least three of the four Amsel criteria are met during follow-up after successful initial treatment.
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 26 Oct 2026.
- Individual participant dataSharing planned: No
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The Genital Microbiome of Male Partners of Women With Recurrent BV Undergoing Vaginal Microbiome Transplantation
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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.
Saima A Professor, FCPS study chair
Nishtar Medical University
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 Probiotic Combination Cap/Tab in people with Recurrent Bacterial Vaginosis, run by Nishtar Medical University at 1 site in Pakistan.
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 2 inclusion and 2 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 26 Oct 2026. 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 Pakistan. 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. Some participants in this study may receive a placebo. 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?
Recurrence of Bacterial Vaginosis (time frame: From confirmation of initial cure through the 4-month follow-up period, with monthly assessments.). 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 26 Oct 2026.