Lactobacilli-containing vaginal probiotics to cure or prevent bacterial or fungal vaginal dysbiosis: a systematic review and recommendations for future trial designs. 2020

Jhhm van de Wijgert, and M C Verwijs
Institute of Infection and Global Health, University of Liverpool, Liverpool, UK.

Vaginal probiotics claiming to cure and/or prevent bacterial and/or fungal vaginal dysbiosis are available on the market but, until recently, did not have to be approved as drugs for human use. We evaluated the impact of vaginal probiotics on bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC) cure and/or recurrence, as well as vaginal microbiota (VMB) composition and vaginal detection of probiotic strains. We performed a systematic literature search in MEDLINE and Embase up to 15 January 2019. There were no restrictions in probiotic strains/formulations, study populations, and designs. BV had to be diagnosed by Nugent or Ison-Hay Gram stain scoring, VVC by culture, wet mount or PCR, and VMB composition/detection by molecular techniques. The authors independently extracted data. All 22 vaginal probiotics evaluated in the 34 eligible studies contained Lactobacillus strains, and some contained additional active ingredients. The probiotics hold promise for BV cure and prevention, but much less so for VVC cure and prevention. No major safety concerns were reported in any of the studies. Vaginal detection of probiotic strains never lasted long beyond the dosing period, suggesting that they did not colonise the vagina. However, findings are not definitive because heterogeneity was high and the quality of most studies suboptimal. Availability of vaginal probiotics for vaginal health indications will likely decline in 2020 because of regulatory changes. We urge the field to invest in clinical evidence-based product development and to conduct future trials more rigorously. Lactobacilli-containing vaginal probiotics hold promise for bacterial vaginosis cure and prevention, but not for vulvovaginal candidiasis.

UI MeSH Term Description Entries
D007778 Lactobacillus A genus of gram-positive, microaerophilic, rod-shaped bacteria occurring widely in nature. Its species are also part of the many normal flora of the mouth, intestinal tract, and vagina of many mammals, including humans. Lactobacillus species are homofermentative and ferment a broad spectrum of carbohydrates often host-adapted but do not ferment PENTOSES. Most members were previously assigned to the Lactobacillus delbrueckii group. Pathogenicity from this genus is rare.
D002181 Candidiasis, Vulvovaginal Infection of the VULVA and VAGINA with a fungus of the genus CANDIDA. Moniliasis, Vulvovaginal,Vaginitis, Monilial,Candidiasis, Genital,Genital Vulvovaginal Candidiasis,Vaginal Yeast Infection,Vaginal Yeast Infections,Candidiasis, Genital Vulvovaginal,Genital Candidiasis,Infection, Vaginal Yeast,Infections, Vaginal Yeast,Monilial Vaginitis,Vulvovaginal Candidiasis,Vulvovaginal Candidiasis, Genital,Vulvovaginal Moniliasis,Yeast Infection, Vaginal,Yeast Infections, Vaginal
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D014621 Vagina The genital canal in the female, extending from the UTERUS to the VULVA. (Stedman, 25th ed) Vaginas
D016585 Vaginosis, Bacterial Polymicrobial, nonspecific vaginitis associated with positive cultures of Gardnerella vaginalis and other anaerobic organisms and a decrease in lactobacilli. It remains unclear whether the initial pathogenic event is caused by the growth of anaerobes or a primary decrease in lactobacilli. Bacterial Vaginosis,Vaginitis, Bacterial,Vaginitis, Nonspecific,Bacterial Vaginitides,Bacterial Vaginitis,Bacterial Vaginoses,Vaginitides, Bacterial,Vaginoses, Bacterial,Nonspecific Vaginitis
D016896 Treatment Outcome Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series. Rehabilitation Outcome,Treatment Effectiveness,Clinical Effectiveness,Clinical Efficacy,Patient-Relevant Outcome,Treatment Efficacy,Effectiveness, Clinical,Effectiveness, Treatment,Efficacy, Clinical,Efficacy, Treatment,Outcome, Patient-Relevant,Outcome, Rehabilitation,Outcome, Treatment,Outcomes, Patient-Relevant,Patient Relevant Outcome,Patient-Relevant Outcomes
D019936 Probiotics Live microbial DIETARY SUPPLEMENTS which beneficially affect the host animal by improving its intestinal microbial balance. Antibiotics and other related compounds are not included in this definition. In humans, lactobacilli are commonly used as probiotics, either as single species or in mixed culture with other bacteria. Other genera that have been used are bifidobacteria and streptococci. (J. Nutr. 1995;125:1401-12) Probiotic
D064307 Microbiota The full collection of microbes (bacteria, fungi, virus, etc.) that naturally exist within a particular biological niche such as an organism, soil, a body of water, etc. Human Microbiome,Microbiome,Microbiome, Human,Microbial Community,Microbial Community Composition,Microbial Community Structure,Community Composition, Microbial,Community Structure, Microbial,Community, Microbial,Composition, Microbial Community,Human Microbiomes,Microbial Communities,Microbial Community Compositions,Microbial Community Structures,Microbiomes,Microbiotas
D064806 Dysbiosis Changes in quantitative and qualitative composition of MICROBIOTA. The changes may lead to altered host microbial interaction or homeostatic imbalance that can contribute to a disease state often with inflammation. Disbacteriosis,Disbiosis,Dys-symbiosis,Dysbacteriosis,Disbacterioses,Disbioses,Dys symbiosis,Dys-symbioses,Dysbacterioses,Dysbioses

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