A Phase 4 interventional study of Probiotic Combination Cap/Tab and Placebo capsules in Recurrent Bacterial Vaginosis, sponsored by Nishtar Medical University. Completed at 1 site in Pakistan. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Nishtar Medical University · Phase 4, Interventional, and Prevention
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:
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.
240 studies on the registry are indexed under Vaginosis, Bacterial; 39 are open to participants now.
This study's enrollment of 70 is below the median of 100 across 203 interventional studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →Nishtar Medical University is the lead sponsor of 29 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Dietary Supplement: Probiotic Combination Cap/Tab
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
Drug: Placebo capsules
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.
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.
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.
Time frame: From confirmation of initial cure through the 4-month follow-up period, with monthly assessments.
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2025 to primary completion in Jan 2026, 5 months.
Of 17 phase 4 interventional studies under Vaginosis, Bacterial, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 41. This study's 5 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Nishtar Medical University