title: Efficacy of rifaximin vaginal tablets in treatment of bacterial vaginosis: a molecular characterization of the vaginal microbiota.
abstract: Bacterial vaginosis (BV) is a common vaginal disorder characterized by an alteration of the vaginal bacterial morphotypes, associated with sexually transmitted infections and adverse pregnancy outcomes. The purpose of the present study was to evaluate the impact of different doses of rifaximin vaginal tablets (100 mg/day for 5 days, 25 mg/day for 5 days, and 100 mg/day for 2 days) on the vaginal microbiota of 102 European patients with BV enrolled in a multicenter, double-blind, randomized, placebo-controlled study. An integrated molecular approach based on quantitative PCR (qPCR) and PCR-denaturing gradient gel electrophoresis (PCR-DGGE) was used to investigate the effects of vaginal tablets containing the antibiotic. An increase in members of the genus Lactobacillus and a decrease in the BV-related bacterial groups after the antibiotic treatment were demonstrated by qPCR. PCR-DGGE profiles confirmed the capability of rifaximin to modulate the composition of the vaginal microbial communities and to reduce their complexity. This molecular analysis supported the clinical observation that rifaximin at 25 mg/day for 5 days represents an effective treatment to be used in future pivotal studies for the treatment of BV.
authors.affiliation: Department of Pharmaceutical Sciences, University of Bologna, Bologna, Italy.
authors.forename: Federica
authors.initials: F
authors.lastname: Cruciani
authors.forename: Patrizia
authors.initials: P
authors.lastname: Brigidi
authors.forename: Fiorella
authors.initials: F
authors.lastname: Calanni
authors.forename: Vittoria
authors.initials: V
authors.lastname: Lauro
authors.forename: Raffaella
authors.initials: R
authors.lastname: Tacchi
authors.forename: Gilbert
authors.initials: G
authors.lastname: Donders
authors.forename: Klaus
authors.initials: K
authors.lastname: Peters
authors.forename: Secondo
authors.initials: S
authors.lastname: Guaschino
authors.forename: Beatrice
authors.initials: B
authors.lastname: Vitali
mesh_terms: D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007778:Lactobacillus / Q000187:drug effects; D054892:Metagenome / Q000187:drug effects*; D008875:Middle Aged; D012336:RNA, Ribosomal, 16S / Q000032:analysis / Q000235:genetics; D012294:Rifamycins / Q000008:administration & dosage*; D000078262:Rifaximin; D014621:Vagina / Q000382:microbiology*; D014622:Vaginal Creams, Foams, and Jellies; D016585:Vaginosis, Bacterial / Q000188:drug therapy* / Q000382:microbiology*; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D012336:RNA, Ribosomal, 16S; D012294:Rifamycins; D014622:Vaginal Creams, Foams, and Jellies; D000078262:Rifaximin