{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["12"],"submitter":["Murina F"],"pubmed_abstract":["<h4>Background</h4>The medical literature has reported that recurrent bacterial vaginosis (RBV) has a relapse rate of 35% within 3 months and 60% within 12 months after antibiotic administration. Products that are able to provide a barrier effect against the biofilm produced by Gardnerella vaginalis could play a role in improving the results of bacterial vaginosis (BV) treatment.<h4>Objective</h4>This study aims to assess the performance and safety of a medical device (Polybactum) containing polycarbophil, lauryl glucoside, and glycerides (PLGG) for reducing the rate of recurrence of BV.<h4>Methods</h4>The study includes women who are aged above 18 years, are willing to provide signed informed consent, have a diagnosis of BV according to the Amsel criteria, and have been affected by at lea"],"journal":["JMIR research protocols"],"pagination":["e42787"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC10401192"],"repository":["biostudies-literature"],"pubmed_title":["Performance and Safety of a New Medical Device (Polybactum) for Reducing the Recurrence Rate of Bacterial Vaginosis: Protocol for a Multicenter, Open-Label, Noncontrolled International Clinical Trial (POLARIS Study)."],"pmcid":["PMC10401192"],"pubmed_authors":["Barattini DF","Ardolino LI","Biris M","Casolati E","Sirbu D","Inghirami P","Mangrella M","Rosu S","Sbrocca F","Murina F","Crisan CD"],"additional_accession":[]},"is_claimable":false,"name":"Performance and Safety of a New Medical Device (Polybactum) for Reducing the Recurrence Rate of Bacterial Vaginosis: Protocol for a Multicenter, Open-Label, Noncontrolled International Clinical Trial (POLARIS Study).","description":"<h4>Background</h4>The medical literature has reported that recurrent bacterial vaginosis (RBV) has a relapse rate of 35% within 3 months and 60% within 12 months after antibiotic administration. Products that are able to provide a barrier effect against the biofilm produced by Gardnerella vaginalis could play a role in improving the results of bacterial vaginosis (BV) treatment.<h4>Objective</h4>This study aims to assess the performance and safety of a medical device (Polybactum) containing polycarbophil, lauryl glucoside, and glycerides (PLGG) for reducing the rate of recurrence of BV.<h4>Methods</h4>The study includes women who are aged above 18 years, are willing to provide signed informed consent, have a diagnosis of BV according to the Amsel criteria, and have been affected by at lea","dates":{"release":"2023-01-01T00:00:00Z","publication":"2023 Jul","modification":"2026-05-29T03:51:06.162Z","creation":"2024-11-06T07:50:43.025Z"},"accession":"S-EPMC10401192","cross_references":{"pubmed":["37471117"],"doi":["10.2196/42787"]}}