In the framework of DIVA (Innovative devices for the prevention of recurrent vaginitis) the Site Initiation Visit at DIMO (Department of Biomedical Sciences and Human Oncology) of the Polyclinic of Bari was held on 7 November 2019. DIVA is a project aimed to develop a specific treatment for vaginitis relapsing with the aim of reducing the antibiotic-therapy.
In particular, this objective is acquired through the development of:
- A food enriched with probiotic lactobacilli with antimicrobial activity and dietary fibres;
- Device / cosmetic with bacteriostatic and fungicidal action derived from plant products;
- Sanitary towels functionalized with bacteria and fungicidal extracts derived from plant products;
In DIVA project, the CVBF will provide support for the clinical trial conduct, with the aim to evaluate the effects of the combination of the double approach (probiotics intestinal and vaginal products) compared to standard therapy in the prevention of recurrent vaginal infections. Moreover, the activities of the CVBF include medical writing, clinical study planning and management, regulatory and ethical activities, pharmacovigilance, data management, monitoring and auditing.
Recently, the first two patients were recruited and involved in the study.
Further details on DIVA project are available at this link.