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Title Lessons Learnt from the First Medicines Control Council Approved Probiotics Trial in South Africa |
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Type Poster Presentation |
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Theme Probiotics and Prebiotics: Excellence in Science and Clinical Translation |
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Topic Regulatory Issues, Especially for the Asia-Pacific Countries |
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Main Author Anna-Ursula Happel1 |
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Presenting Author Anna-Ursula Happel1 |
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Co-Author Jo-Ann Passmore1 2 3 Heather Jaspan1 4 Shaun Barnabas1 |
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Department / Institution / Country Pathology / University of Cape Town / South Africa1 Immunology / DST-NRF Centre of Excellence in HIV Prevention / South Africa2 Immunology / National Health Laboratory Service / South Africa3 Seattle Children’s Research Institute / University of Washington / United States4 |
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Background and Rationale Bacterial vaginosis (BV) increases acquisition of sexually-transmitted infections (STI), including HIV, and adverse reproductive outcomes. The current standard of care for BV, antibiotics, are not effective long-term, with 6-month recurrence rates of 50%. There is thus an urgent need for durable treatment of BV. Biotherapeutics, including adjunctive probiotics, may improve efficacy and durability. No randomized trial comparing antibiotic treatment to probiotics as an adjunct to antibiotics has been performed in South Africa. |
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Objectives: Indicates the purpose of the study A single-blind, randomized controlled trial enrolling BV positive, STI negative South African women with vaginal discharge was initiated to compare standard of care (metronidazole, n=20) to a combination of metronidazole and a commercially-available probiotic for vaginal health sold in South Africa (n=30). |
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Methodology: Describe pertinent experimental procedures The primary endpoint is BV status at one month. Secondary endpoints are durability of treatment, changes in genital inflammatory milieu, microbiome and presence of the probiotic bacteria in the vagina over six months after enrolment. |
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Results: Summarize the results of the research This is the first probiotics trial in South Africa that was approved by the regulatory authorities, the Medicines Control Council (MCC), thus laying the goundwork for the local regulatory landscape. Intense education of doctors, nurses and participants about probiotics has facilitated the recruitment. Enrollment and follow-up are ongoing although preliminary results show that screening based on vaginal symptoms alone has high screen-failure rate, suggesting the use of BV rapid tests in pre-screening. This study describes the regulatory framework by which probiotics are regulated within South Africa and the hurdles that need to be overcome to enable testing of products not currently approved by the MCC. |
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Conclusions: State the main conclusions Well-designed, clinical trials are needed in South Africa to asses the efficacy of adjunctive biotherapeutics for BV treatment. Vaginal discharge poorly predicts BV. The regulatory landscape for probiotics in South Africa is evolving and communication between scientists, clinical staff, participants and regulatory authorities are needed. |