Lessons learnt from the first South African Health Products Regulatory Authority (SAHPRA)-approved probiotics trial to improve cure of bacterial vaginosis (BV) in a region with high BV and HIV rates
Anna-Ursula Happel1, Ravesh Singh2,3, Nireshni Naidoo2,3, Koleka Mlisana2,3, Heather Jaspan1,4, Shaun Barnabas1, Jo-Ann Passmore*,1,2,5 *Corresponding author 1Institute of Infectious Disease and Molecular Medicine, University of Cape Town, South Africa; 2National Health Laboratory Service, Cape Town, South Africa; 3Department of Medical Virology, University of KwaZulu Natal, South Africa; 4Seattle Children's Hospital, USA; 5SAMRC Gynaecological Cancer Research Centre, South Africa
BV is associated with genital inflammation, increased HIV risk and adverse reproductive outcomes. The standard of care for BV is antibiotics, although recurrence is high. In combination with antibiotics, biotherapeutics may improve efficacy and durability of BV treatment. No randomized trial comparing antibiotic treatment of BV to adjunctive vaginal probiotics has been conducted in South Africa, and no probiotic trial has yet been approved by SAHPRA. A single-blind, randomized controlled trial in STI- BV+ women with abnormal vaginal discharge compared metronidazole (n=20) to metronidazole with a commercially available oral/vaginal probiotic, available over-the-counter (OTC) in South Africa (n=30). The primary endpoint was BV cure (assesed by Nugent Score) at one-month. Among screened women, the BV prevalence was 56.5 %, while 25.7% of BV+women also had a STI. Vaginal discharge was a poor predictor for BV. To date, 23/50 have completed the trial. Preliminary results showed a high rate of STI aquistion during the study (20% incidence). The probiotic was well-accepted and no study-product related adverse events were reported. An interim analysis suggests no beneficial effects of the probiotic on BV cure and genital inflammation compared to metronidazole alone, although BV recurrence was lower. Similar concentrations of beneficial Lactobacillus spp. and a similar decrease in BV-associated spp. was found in both groups. Although explicitly marketed for vaginal health, the probiotic tested did not contain Lactobacillus spp. typically found in the vagina. This product provided little benefit to improving BV cure compared to metronidazole alone, although recurrence was lower. Importantly, this first to be registered by SAHPRA trial has laid the path for furture probiotic testing in South Africa.
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