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

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.

Probiotics are a good choice for the treatment of Bacterial Vaginosis: a meta-analysis of randomized controlled trial

“…Funnel plots suggested the heterogeneity between those studies. (Figure 3) G1: Fourteen randomized controlled trials [24][25][26][27][28][29][30][31][32][33][34][35][36][37] compared the e cacy of probiotic-assisted antibiotic therapy for BV with antibiotics alone (or plus placebo), including data from 1662 patients with BV. The cure rate was 72.98% (624/855) in the antibiotics + probiotics group and 62.70% (506/807) in the antibiotics (+placebo) group, with P = 0.009, reaching a statistically signi cant difference.…”

Probiotics are a good choice for the treatment of bacterial vaginosis: a meta-analysis of randomized controlled trial

“…G1: Fourteen randomized controlled trials [ 19 , 24 – 36 ] compared the efficacy of probiotic-assisted antibiotic therapy for BV with antibiotics alone (or plus placebo), including data from 1662 patients with BV. The cure rate was 72.98% (624/855) in the antibiotics + probiotics group and 62.70% (506/807) in the antibiotics (+placebo) group, with P = 0.009, reaching a statistically significant difference.…”

Probiotic Lacticaseibacillus rhamnosus GR-1 and Limosilactobacillus reuteri RC-14 as an Adjunctive Treatment for Bacterial Vaginosis Do Not Increase the Cure Rate in a Chinese Cohort: A Prospective, Parallel‐Group, Randomized, Controlled Study

“…Although previous studies indicated that oral probiotics could contribute to the recovery of the vaginal microbiota and that probiotic species or strains could be detected in the vagina after oral probiotic administration (Anukam et al, 2006;Vujic et al, 2013;Heczko et al, 2015;Macklaim et al, 2015;Russo et al, 2018), contrary views still exist (Happel et al, 2020;Husain et al, 2020). A recent study from Reid et al demonstrated that oral intake of L. rhamnosus GR-1 and L. reuteri RC-14 did not change the vaginal microbiota significantly in low-risk pregnant women through the assessment of both Nugent Gram stain scoring and high-throughput sequencing (Yang et al, 2020).…”

“…Although previous studies indicated that oral probiotics could contribute to the recovery of the vaginal microbiota and that probiotic species or strains could be detected in the vagina after oral probiotic administration ( Anukam et al., 2006 ; Vujic et al., 2013 ; Heczko et al., 2015 ; Macklaim et al., 2015 ; Russo et al., 2018 ), contrary views still exist ( Happel et al., 2020 ; Husain et al., 2020 ). A recent study from Reid et al.…”