Metronidazole Versus lactic acId for Treating bacterial vAginosis–VITA
Research type
Research Study
Full title
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
IRAS ID
208149
Contact name
Jonathan Ross
Contact email
Sponsor organisation
University Hospitals Birmingham NHS Foundation Trust
Eudract number
2016-004483-19
Duration of Study in the UK
3 years, 8 months, 30 days
Research 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 antibiotics 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 advance our understanding by assessing whether intravaginal lactic acid gel is effective and safe for the treatment of recurrent bacterial vaginosis, and can reduce antibiotic usage.
The objective of the study is to determine if intravaginal lactic acid gel is better than oral metronidazole tablets for the symptomatic resolution of BV symptoms.
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 not need to attend their clinic again but will be provided with a kit to take their own vaginal samples at home 2 weeks after starting their study treatment. These samples will be analysed for the presence of BV following their study treatment and also to test for the presence of concurrent STI's (chlamydia, gonorrhoea, trichomonas). In addition participants will complete 3 online questionnaires at week 2, 3 months and 6 months reporting any side effects of their study treatment, how their BV symptoms are, any new episodes of BV they experience and whether they have had to take any additional treatments for their BV.
REC name
London - Harrow Research Ethics Committee
REC reference
17/LO/1245
Date of REC Opinion
9 Sep 2017
REC opinion
Further Information Favourable Opinion