This is a prospective, clinical, multicentre study aimed to collect biological samples and study microbiota from subjects with Clostridium Difficile (CDI), subjects affected by Multi Drug Resistant Organisms (MDRO) infection, subjects with Chronic Inflammatory Bowel Disease (IBD), subjects with Irritable Bowel Syndrome (IBS), subjects with Hepatic Encephalopathy 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: * Provide biological samples (faeces, saliva, blood, urine) from healthy volunteers and patients to the first Italian microbiota biobank; * Study microorganisms using different in vitro and in vivo techniques; * Study the link between the microbiota and the disease. This study is part of the BIOMIS project (Project Code: ARS01\_01220), presented as part of the "Avviso per la presentazione di progetti di ricerca industriale e sviluppo sperimentale nelle 12 aree di specializzazione individuate dal PNR 2015-2020" and admitted to funding under the National Operational Program "Ricerca e Innovazione" 2014-2020 by directorial decree of MIUR - Department for Higher Education and Research - n. 2298 of 12 September 2018. BIOMIS includes several clinical studies that enrol patients with different pathologies to collect and store biological samples and study microbiota.
The primary aim of this multicentric study is to populate the first national microbioma biobank with biological samples (fecal, salivary, urinary and blood samples) subjects suffering from selected disease (CDI, MDRO, IBD, IBS and Hepatic Encephalopathy), 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 225 subjects at Policlinico of Bari, University of Perugia and Policlinico Agostino Gemelli Rome, 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: * Visit 0 (V0), including description of the objectives and procedures study, signature written informed consent, inclusion/exclusion criteria evaluation, medical examination (blood pressure measurement, abdominal and thoracic physical examination), filling in of the anamnestic questionnaire, delivery of the coproculture kit, delivery of kits for the collection of fecal, salivary and urinary material to be reported at Visit 1 and delivery of a 3-day food diary, to be completed autonomously in the days preceding the Visit 1. * Visit 1 (V1) - at least 4 days after V0, including delivery of the of the collected biological material (feces, saliva, urine), and of a 3-day food diary, filling in of the new signs and symptoms anamnestic questionnaire and blood sampling by medical staff. For MDRO patients rectal swab collection. * Telephone evaluation: administration of a "Food Frequency Questionnaire" to assess the subjects' alimentary habits. 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: * routine screening; * storage in the first Italian human microbiote biobank (I.R.C.C.S. - Istituto Tumori "Giovanni Paolo II", Bari); * evaluation of the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile; * Evaluation of the transcriptomic profile of PBMCs of healthy subjects and subjects affected by selected pathologies and evaluation of the serum proteomic profile 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). Also, in vitro studies on mucosal models to evaluate the interaction between the microbiota and the intestinal mucosa will be conducted. 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.
Study Type
OBSERVATIONAL
Enrollment
225
Collection of faeces, coproculture examination, urine, saliva, PBMC and blood for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening. Analysis for the identification, quantification and characterization of health-promoting bacteria
Anamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire
Blood pressure measurement, abdominal and thoracic physical examination
Azienda Ospedaliera Universitaria Policlinico di Bari - Sezione di Malattie dell'Apparato Digerente, Endoscopia e Trapianto di Fegato (D.E.T.O.)
Bari, Italy
Università degli Studi di Perugia - Dipartimento di Medicina
Perugia, Italy
Centro Malattie Apparato Digerente - CEMAD, Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, Italy
Biological samples collection for establishment of the first National Microbiome Biobank
Recruitment of 225 subjects (CDI, MDRO, IBD, IBS, Hepatic Encephalopathy patients and healthy volunteers) to collect biological samples for establishment of the first National Microbiome Biobank
Time frame: through study completion, an average of 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.