Establishment of the Human Intestinal and Salivary Microbiota Biobank - Gastrointestinal Diseases

Summary

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.

Conditions

• Clostridium Difficile Infection
• Multi Drug Resistant Organisms
• Chronic Inflammatory Bowel Disease
• Irritable Bowel Syndrome
• Hepatic Encephalopathy

Interventions

OTHER

Biological sample collection

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

OTHER

Questionnaire

Anamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire

OTHER

Medical examination

Blood pressure measurement, abdominal and thoracic physical examination

Sponsors & Collaborators

• Istituti Tumori Giovanni Paolo II

  collaborator NETWORK

• University of Bari Aldo Moro

  collaborator OTHER

• University of Salento

  collaborator OTHER

• University Of Perugia

  collaborator OTHER

• Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies

  collaborator OTHER

• Catholic University of the Sacred Heart

  collaborator OTHER

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

  lead OTHER

Principal Investigators

• Giuseppe Losurdo, MD · Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-02-08

Primary Completion

2022-05-10

Completion

2022-05-10

Countries

• Italy

Study Locations