Costituzione Della Biobanca Del Microbiota Intestinale e Salivare Umano: Dalla Disbiosi Alla Simbiosi
Costituzione Della Biobanca Del Microbiota Intestinale e Salivare Umano: Dalla Disbiosi Alla Simbiosi
This is a prospective, clinical, monocentric study aimed to collect biological samples and study microbiota from subjects suffering from subjects with recurrent cervicovaginitis, subjects with endometriosis, subjects with repeated implantation failures and from healthy volunteers. Microbiota is a complex consortium of microorganisms, located at the mucosal level (in particular intestinal, oral and vaginal) having a key role in human health and in the onset of several diseases. Microbiota alterations have been found in several diseases (gastrointestinal, metabolic, renal, oncological, gynaecological).
The study will allow to:
The primary aim of this monocentric study is to populate the first national microbioma biobank with biological samples (fecal, salivary, urinary and vaginsl samples) subjects suffering from selected disease disease and healthy volunteers.
The secondary aim is the characterization of microorganisms of the biobank and study of the microbiota-pathology relationship using meta-omics, in vitro and in vivo approaches, The study plans to enrol 100 subjects at Policlinic of Bari, according to the inclusion/exclusion criteria. The study participation is voluntary, and the subjects have the right to withdraw from the study at any time and for any reason.
During the study, 3 visits are planned:
Standard Operative Procedures (SOP) for samples storing, transport and processing will be adopted to ensure samples stability and grant results validity and quality.
Following collections, samples will be processed in different aliquots that will be used for:
Furthermore, molecular characterization of pathogenic microorganisms and pathogenic biotypes (pathovars) of commensal species of subjects with selected pathologies will be conducted.
Part of the biological material will be used for animal studies on the physiopathological role of the human intestinal microbiota transplanted into mouse models of pathology and Germ-free mouse models (specific animal study protocol developed).
The study foresees no more than minimal risk associated with blood sampling procedures. All the necessary measures to avoid any risks / inconveniences resulting from participation of the subject under study will be taken.
The study is compliant with Good Clinical Practice. Study protocol and all related documents have been approved by approved by the Independent Ethics Committees (IEC) of the involved clinical sites.
To ensure the protection and confidentiality of the participants' data, all study activities will be carried out in accordance with the European General Data Protection Regulation, Regulation (EU) 2016/679, which repeals Directive 95/46/EC.
Inclusion Criteria:
HEALTHY VOLUNTEERS
PATIENTS WITH RECIDIVING CERVIC VAGINITIS
PATIENTS WITH ENDOMETRIOSIS
Inclusion criteria:
PATIENTS WITH REPEATED IMPLANT FAILURES (RIF)
Inclusion criteria:
Exclusion Criteria:
HEALTHY VOLUNTEERS
Exclusion criteria:
POPULATION 2 - PATIENTS WITH RECIDIVING CERVIC VAGINITIS/ POPULATION 3 - PATIENTS WITH ENDOMETRIOSIS/ POPULATION 4 - PATIENTS WITH REPEATED IMPLANT FAILURES (RIF)