VITA

VITA: A randomised controlled trial to assess the clinical and cost effectiveness of topical lactic acid gel for treating second and subsequent episodes of bacterial vaginosis

Project Summary 

Currently the antibiotic metronidazole is used to treat bacterial vaginosis (BV), which is effective in the short term but has a high rate of recurrence (30%) within the subsequent 3 months, which results in repeated antibiotic use and the associated adverse events.

The use of topical lactic acid gel is not currently recommended in BV treatment guidelines due to a lack of evidence from well-designed randomised trials. The proposed trial will assess whether intravaginal lactic acid gel is effective and safe for the treatment of recurrent bacterial vaginosis, and can reduce antibiotic usage.

The study will compare the effect of intravaginal lactic acid gel with that of oral metronidazole tablets for the symptomatic resolution of BV symptoms in an open-label randomised controlled trial.

Patients with a history of recurrent BV will be recruited into the study from GP practices, sexual health centres and gynaecology clinics. Participants who are eligible will provide vaginal samples (swabs and smears) during their baseline visit and will be randomised to receive either 7 days of metronidazole tablets or lactic acid gel as their study treatment. 

Participants will be followed-up with home sampling and on-line questionnaires (no clinic follow-up is required). The samples will be analysed for the presence of BV following the study treatment and will also be tested for the presence of concurrent STIs.