CompletedPhase 3Phase 4ACTRN12607000350426

Bacterial Vaginosis Antibiotic Probiotic Study

A randomised placebo-controlled trial to test the addition of vaginal clinidamycin or probiotic to oral metronidazole in the treatment of bacterial vaginosis


Sponsor

Bayside Health

Enrollment

450 participants

Start Date

Sep 1, 2007

Study Type

Interventional

Conditions

Summary

To determine if the addition of either topical clindamycin or a topical probiotic/oestrogen combination, reduces recurrent rates of bacterial vaginosis (BV), when added to the current recommended therapy of seven days of the oral antibiotic metronidazole. Hypotheses 1. Combination antibiotic therapy of oral metronidazole with vaginal clindamycin will be more effective than oral metronidazole alone in the treatment of bacterial vaginosis. 2. Restoring normal vaginal acidity and healthy bacteria through replacement of Lactobacillus bacteria and topical oestrogen (in addition to oral metronidazole), will achieve higher rates of cure than current recommended therapy oral metronidazole alone.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

This study investigates Bacterial Vaginosis Antibiotic Probiotic Study. It is looking for women only, aged 18 to 45 who have women with BV on Nugent's criteria. People who are pregnant or breastfeeding individuals cannot take part. If you are interested, you may need to attend study visits and follow the research team's instructions.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

3 armed trial. All women received 400mg twice daily oral metronidazole for 7 days, and concurrently randomised to also receive either vaginal topical 2% clindamycin cream (1 applicator full once daily

3 armed trial. All women received 400mg twice daily oral metronidazole for 7 days, and concurrently randomised to also receive either vaginal topical 2% clindamycin cream (1 applicator full once daily for 7 days); vaginal topical probiotic (L.acidophilus KS400)/0.03mg oestriol pessary (one pessary once daily for 12 days) or placebo pessary (one pessary once daily for 12 days).


Locations(1)

Australia

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ACTRN12607000350426