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
Date
2020-07-10
Journal Title
Journal ISSN
Volume Title
Publisher
BMC (part of Springer Nature)
Abstract
Background: Bacterial vaginosis (BV) increases HIV risk and adverse reproductive outcomes. Standard-of-care (SOC) for BV are antibiotics; however, cure rates are low. Probiotics for vaginal health may be useful in improving cure
and recurrence although the regulatory framework governing probiotics and the conduct of randomized clinical
trials to evaluate these has not been established in South Africa. We performed an exploratory single-blind trial
evaluating a commercial oral-vaginal-combination probiotic as adjunct to SOC for BV treatment.
Methods: Women with symptomatic vaginal discharge were screened for BV and common sexually transmitted
infections (STIs). BV+ (Nugent 7–10) but STI- women were randomized to vaginal metronidazole alone (n = 12) or to
metronidazole followed by a commercial oral/vaginal probiotic (n = 18). The primary qualitative outcome was to
test the regulatory landscape for conducting randomized probiotic trials in South Africa; and acceptability of vaginal
application by women. BV cure at 1 month (Nugent≤3) was the primary quantitative endpoint. Secondary
quantitative endpoints were BV recurrence, symptoms, vaginal microbiota and genital cytokine changes over 5
months post-treatment.
Results: The South African Health Products Regulatory Authority (SAHPRA) reviewed and approved this trial. As
probiotics continue to be regulated as health supplements in South Africa, SAHPRA required a notification
application for this trial. Acceptability and adherence to the oral and vaginal application of the probiotic were high,
although women reported a preference for oral capsules. 44.8% of women cleared BV one-month post-treatment,
and no significant differences in BV cure (RR = 0.52, 95% CI = 0.24–1.16), recurrence, vaginal pH, symptoms,
microbiota or vaginal IL-1α concentrations were found between SOC and intervention groups in this pilot study
with an over-the-counter product.
Conclusion: Navigation of the SAHPRA registration process for evaluating a commercial probiotic in a randomised
trial laid the foundation for planned larger trials of improved probiotic products for vaginal health in South Africa.
Although adherence to the vaginally delivered probiotic was high, women preferred oral application and we
recommend that improvements in the content and method of application for future probiotics for vaginal health
should be considered.
Description
CITATION: Happel, A. U., et al. 2020. 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. BMC Infectious Diseases, 20:491, doi:10.1186/s12879-020-05210-4.
The original publication is available at https://bmcinfectdis.biomedcentral.com
The original publication is available at https://bmcinfectdis.biomedcentral.com
Keywords
Probiotics, Vagina -- Diseases -- Treatment -- South Africa, Bacterial vaginitis -- Treatment, Microorganisms -- Development -- South Africa
Citation
Happel, A. U., et al. 2020. 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. BMC Infectious Diseases, 20:491, doi:10.1186/s12879-020-05210-4