Costituzione Della Biobanca Del Microbiota Intestinale e Salivare Umano: Dalla Disbiosi Alla Simbiosi
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 225
- Locations
- 3
- Primary Endpoint
- Biological samples collection for establishment of the first National Microbiome Biobank
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •Subjects > 18 years old
- •Subjects colonised for MDRO diagnosed with rectal swab
- •Negative parasitological faeces culture for Giardia lamblia, Entamoeba histolytica / dispar, Cryptosporidium parvum and other parasites.
- •Negative faeces culture for C. difficile, Salmonella spp., Shigella spp., Yersinia enterocolitica, Campylobacter, Streptococcus agalactiae, Staphylococcus aureus, enteropathogens Escherichia coli
- •Signature of informed consent.
- •PATIENTS WITH IBD
- •Age> 18 years.
- •Individuals available for scheduled visits, treatment plan, laboratory tests, lifestyle guidelines, and other study procedures.
- •Subjects with a documented diagnosis of ulcerative colitis or Crohn's at least 6 months before screening.
- •Signature of informed consent.
- •PATIENTS WITH IBS
- •Subjects diagnosed with IBS according to Rome IV criteria
- •Age between 18 and 60 years
- •BMI between 18.5-30
- •Omnivorous diet
- •Signature of informed consent
- •PATIENTS WITH HEPATIC ENCEPHALOPATHY
- •Subjects with hepatic encephalopathy
- •Age between 18 and 60 years
- •BMI between 18.5-30
- •Omnivorous diet
- •Signature of informed consent
- •Exclusion criteria:
- •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)
- +80 more not shown
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Biological samples collection for establishment of the first National Microbiome Biobank
Time Frame: through study completion, an average of 1 year
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
Secondary Outcomes
No secondary outcomes reported