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

NCT04698148 | Completed

• 1 other identifier: BIOMIS-Gastr
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Microbioma biobank; Biological human samples; Gastrointestinal disease; Meta-omics approaches; Microbiota-pathology relationship

Outcome Measures

Primary Outcomes (1)

• 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

  through study completion, an average of 1 year

Study Arms (6)

CDI patients

Patients with Clostridium Difficile Infection

Other: Biological sample collection; Other: Questionnaire; Other: Medical examination

MDRO patients

Patients with Multi Drug Resistant Organisms infection

Other: Biological sample collection; Other: Questionnaire; Other: Medical examination

IBD patients

Patients with Chronic Inflammatory Bowel Disease

Other: Biological sample collection; Other: Questionnaire; Other: Medical examination

IBS patients

Patients with Irritable Bowel Syndrome

Other: Biological sample collection; Other: Questionnaire; Other: Medical examination

Hepatic Encephalopathy patients

Patients with Hepatic Encephalopathy

Other: Biological sample collection; Other: Questionnaire; Other: Medical examination

healthy volunteers

healthy volunteers

Other: Biological sample collection; Other: Questionnaire; Other: Medical examination

Interventions

Biological sample collection OTHER

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

CDI patients; Hepatic Encephalopathy patients; IBD patients; IBS patients; MDRO patients; healthy volunteers

Questionnaire OTHER

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

CDI patients; Hepatic Encephalopathy patients; IBD patients; IBS patients; MDRO patients; healthy volunteers

Medical examination OTHER

Blood pressure measurement, abdominal and thoracic physical examination

CDI patients; Hepatic Encephalopathy patients; IBD patients; IBS patients; MDRO patients; healthy volunteers

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with C. Difficile (CDI), subjects affected by Multi Drug Resistant Organisms (MDRO) infection, subjects with Chronic Inflammatory Bowel Disease (IBD), subjects suffering from Irritable Bowel Syndrome (IBS) and subjects with Hepatic Encephalopathy attending one of the clinical centres involved in the study. Healthy volunteers will be recruited by invitation. Enrolled subjects must not have any family relationship and hierarchical subordination with the hospitals in which biological samples will be collected.

You may qualify if:

• HEALTHY VOLUNTEERS
• healthy subjects aged between 18 and 60 years
• BMI between 18.5-30
• omnivorous diet
• signature of the informed consent
• PATIENTS WITH CDI
• subjects with CDI \> 18 years
• Symptomatic recurrent CDI infection, diagnosed by toxin search (ELISA)
• Subjects eligible for antibiotic treatment in accordance with European guidelines
• Possibility of being subjected to the diagnostic and therapeutic procedures of the study
• Negative parasitological examination of stools for Giardia lamblia, Entamoeba histolytica / dispar, Cryptosporidium parvum, and other parasites.
• Negativity of co-culture for Salmonella spp., Shigella spp., Yersinia enterocolitica, Campylobacter, Streptococcus agalactiae, Staphylococcus aureus, enteropathogenic Escherichia coli and other microorganisms with the exception of Clostridium difficile
• Negativity of the following serological tests: HAV-IgM, HBsAg, Anti-HCV, Anti-HIV1-2, VDRL
• Signature of the informed consent
• PATIENTS WITH MDRO

You may not qualify if:

• Healthy volunteers
• Current or previous infectious diseases (HAV, HBV, HCV, HIV, Cytomegalovirus, Epstein-Barr virus)
• Chronic liver disease
• History of Clostridium difficile infections
• Recent (\<3 months) therapy with antibiotics, immunosuppressive drugs, chemotherapy
• Chronic therapy with proton pump inhibitors
• Recent (\<3 months) use of probiotics, laxatives or other aids (drugs / supplements) for the regulation of gastrointestinal activity
• Previous history of organ / tissue transplantation
• Recent onset of diarrhea
• Chronic diarrhea
• Chronic constipation
• Previous gastrointestinal surgery (eg gastric bypass)
• Recurring urinary tract infections (3 cases per year)
• Previous major acute cardiovascular diseases (myocardial infarction, stroke)
• Type 2 diabetes mellitus

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: lead
• Istituti Tumori Giovanni Paolo II: collaborator
• University of Bari Aldo Moro: collaborator
• University of Salento: collaborator
• University Of Perugia: collaborator
• Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies: collaborator
• Catholic University of the Sacred Heart: collaborator

Study Sites (3)

Azienda Ospedaliera Universitaria Policlinico di Bari - Sezione di Malattie dell'Apparato Digerente, Endoscopia e Trapianto di Fegato (D.E.T.O.)

Bari, Italy

Location

Università degli Studi di Perugia - Dipartimento di Medicina

Perugia, Italy

Location

Centro Malattie Apparato Digerente - CEMAD, Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

Roma, Italy

Location

Related Publications (5)

• Aira A, Feher C, Rubio E, Soriano A. The Intestinal Microbiota as a Reservoir and a Therapeutic Target to Fight Multi-Drug-Resistant Bacteria: A Narrative Review of the Literature. Infect Dis Ther. 2019 Dec;8(4):469-482. doi: 10.1007/s40121-019-00272-7. Epub 2019 Oct 25.

  PMID: 31654298 BACKGROUND

• Rivera-Flores R, Moran-Villota S, Cervantes-Barragan L, Lopez-Macias C, Uribe M. Manipulation of microbiota with probiotics as an alternative for treatment of hepatic encephalopathy. Nutrition. 2020 May;73:110693. doi: 10.1016/j.nut.2019.110693. Epub 2019 Dec 6.

  PMID: 32065881 BACKGROUND

• Yoon YK, Suh JW, Kang EJ, Kim JY. Efficacy and safety of fecal microbiota transplantation for decolonization of intestinal multidrug-resistant microorganism carriage: beyond Clostridioides difficile infection. Ann Med. 2019 Nov-Dec;51(7-8):379-389. doi: 10.1080/07853890.2019.1662477. Epub 2019 Sep 13.

  PMID: 31468999 BACKGROUND

• Ni J, Wu GD, Albenberg L, Tomov VT. Gut microbiota and IBD: causation or correlation? Nat Rev Gastroenterol Hepatol. 2017 Oct;14(10):573-584. doi: 10.1038/nrgastro.2017.88. Epub 2017 Jul 19.

  PMID: 28743984 BACKGROUND

• Rajilic-Stojanovic M, Jonkers DM, Salonen A, Hanevik K, Raes J, Jalanka J, de Vos WM, Manichanh C, Golic N, Enck P, Philippou E, Iraqi FA, Clarke G, Spiller RC, Penders J. Intestinal microbiota and diet in IBS: causes, consequences, or epiphenomena? Am J Gastroenterol. 2015 Feb;110(2):278-87. doi: 10.1038/ajg.2014.427. Epub 2015 Jan 27.

  PMID: 25623659 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

faeces, saliva, blood, serum, urine, PBMC

MeSH Terms

Conditions

Clostridium Infections; Irritable Bowel Syndrome; Hepatic Encephalopathy; Gastrointestinal Diseases

Interventions

Surveys and Questionnaires; Independent Medical Evaluation

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Liver Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Giuseppe Losurdo, MD

  Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: January 6, 2021
• Study Start: February 8, 2021
• Primary Completion: May 10, 2022
• Study Completion: May 10, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)