An exploratory pilot study evaluating the supplementation of standard antibiotic therapy with probiotic lactobacilli in south African women with bacterial vaginosis
Autor: | Kennedy Otwombe, Harold Marcotte, Fanglei Zuo, Glenda Gray, Lasse Sommer Mikkelsen, Erik Brandsborg, Fatima Laher, Kasper Krogh Andersen, Per Larsson |
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Jazyk: | angličtina |
Rok vydání: | 2019 |
Předmět: |
0301 basic medicine
Pilot Projects law.invention South Africa Probiotic Lactobacillus gasseri DSM 14869 law Prospective Studies Lactobacillus rhamnosus DSM 14870 biology Vaginosis Bacterial Bacterial vaginosis Anti-Bacterial Agents Treatment Outcome Infectious Diseases medicine.anatomical_structure Doxycycline Vagina Female medicine.symptom Research Article medicine.drug Adult Vaginal discharge medicine.medical_specialty Adolescent 030106 microbiology Reproduktionsmedicin och gynekologi Lactobacillus gasseri lcsh:Infectious and parasitic diseases Young Adult 03 medical and health sciences Lactobacillus Probiotics Lactobacillus rhamnosus Cefixime Metronidazole Internal medicine Obstetrics Gynecology and Reproductive Medicine medicine Humans lcsh:RC109-216 business.industry biology.organism_classification medicine.disease 030104 developmental biology business |
Zdroj: | BMC Infectious Diseases, Vol 19, Iss 1, Pp 1-15 (2019) BMC Infectious Diseases |
Popis: | Background To reduce acquisition and relapse of bacterial vaginosis (BV), lactobacilli must be maintained in the vaginal microbiome. Probiotic lactobacilli may aid this purpose. We investigated whether vaginal probiotics (containing Lactobacillus rhamnosus DSM 14870 and Lactobacillus gasseri DSM 14869) would result in vaginal colonisation with lactobacilli in women with and without BV. Methods This prospective, partially randomised, exploratory pilot study was conducted in Soweto, South Africa. Thirty-nine sexually-active, HIV negative women were enrolled from October 2014 to May 2016 into three arms. Women who did not have BV (Group 1, n = 13) self-administered probiotic capsules vaginally once daily for 30 days, then once a week until Day 190. Women diagnosed with BV were randomized into Group 2 (n = 12) or Group 3 (n = 14) and treated with the triple oral antibiotic combination for vaginal discharge syndrome per South African guidelines (cefixime 400 mg stat, doxycycline 100 mg BD for 7 days and metronidazole 2 g stat). Immediately after antibiotic treatment, women in Group 2 self-administered probiotic capsules vaginally once daily for 30 days then vaginally once a week until Day 190. Women in Group 3 were not given lactobacilli. Results During the study, L. rhamnosus DSM 14870 or L. gasseri DSM 14869, were isolated in 5/13 (38.5%) women in Group 1 compared to 10/12 (83.3%) women in Group 2 (p = 0.041). The 1-month and 6-month BV cure rates were similar (P > 0.05) between Group 2 (42 and 25%) compared to Group 3 (36 and 25%). In Group 2, no correlation was observed between the frequency of isolation of the two Lactobacillus strains and the 1-month or 6-month cure rate. Conclusions Supplementation with vaginal probiotic capsules resulted in colonisation of the vagina by the Lactobacillus strains (L. rhamnosus DSM 14870 and L. gasseri DSM 14869) contained in the capsules. We observed low initial cure rates of BV after a stat dose of metronidazole and that the probiotic did not improve BV cure rates or alleviate recurrence which could be due to treatment failure or very limited power of the study. Trial registration Registered at the Pan African Clinical Trial Registry (www.pactr.org) on April 13, 2018 (retrospectively registered). Trial identification number: PACTR201804003327269. |
Databáze: | OpenAIRE |
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