Testing the regulatory framework in South Africa – a single-blind randomized pilot trial of commercial probiotic supplementation to standard therapy in women with bacterial vaginosis

摘要

Consort diagram. A total of 96 women with symptomatic discharge were screened for eligibility Participants were tested for BV by Nugent Scoring on for STIs (including C. trachomatis, T. vaginalis, M. genitalium and N. gonorrhoeae) by Multiplex PCR. Eligible participants (BV positive but STI negative) were randomly assigned to the SOC (metronidazole only) or intervention arm (metronidazole plus probiotic). Follow-up visits took place 1, 3 and 5 months post-treatment. LTFU = lost to follow up