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Status:

COMPLETED

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

Lead Sponsor:

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Collaborating Sponsors:

Istituti Tumori Giovanni Paolo II

University of Bari Aldo Moro

Conditions:

Clostridium Difficile Infection

Multi Drug Resistant Organisms

Eligibility:

All Genders

18-60 years

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 Or...

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 di...

Eligibility Criteria

Inclusion

  • 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)
  • Recurring urinary tract infections (3 cases per year)
  • Previous major acute cardiovascular diseases (myocardial infarction, stroke)
  • Type 2 diabetes mellitus
  • Hypertension
  • eGFR (estimated glomerular filtration rate) lower than 60ml / minute and / or diagnosis of nephropathy
  • Chronic gastrointestinal disorders
  • Systemic inflammatory diseases
  • Suspicion, clinical diagnosis or previous history of cancer (\<5 years)
  • Autoimmune disorders or history of chronic and systemic autoimmune disorders
  • Neurodegenerative disorders
  • Pregnancy and breastfeeding
  • Healthcare workers
  • Operators work with animals
  • Psychiatric conditions that reduce protocol compliance.
  • Patients with CDI
  • Age \<18 years
  • Negative detection of Clostridium difficile toxin in faeces by ELISA method
  • Severe clinical condition (sepsis, severe dehydration, important co-morbidities)
  • Previous i.c. total or partial colectomy
  • High risk of post-colonoscopy complications
  • Other causes of symptoms similar to those caused by CDI, such as other infections, inflammatory bowel diseases or irritable bowel syndrome
  • Positive parasitological examination of stool for Giardia lamblia, Entamoeba histolytica / dispar, Cryptosporidium parvum, and other parasites
  • Copro-culture positive for Salmonella spp., Shigella spp., Yersinia enterocolitica, Campylobacter, Streptococcus agalactiae, Staphylococcus aureus, enteropathogenic Escherichia coli and other microorganisms except for Clostridium difficile
  • Positivity of the following serological tests: HAV-IgM, HBsAg, Anti-HCV, Anti-HIV1-2, VDRL
  • Pregnancy or breastfeeding
  • Psychiatric conditions that reduce protocol compliance
  • Patients with MDRO
  • Subjects \<18
  • Subjects unable to perform or intolerant to lower endoscopy
  • Subjects negative for rectal swab MDRO
  • Positivity for parasitological faeces culture for Giardia lamblia, Entamoeba histolytica / dispar, Cryptosporidium parvum and other parasites.
  • Positive faeces culture for C. difficile, Salmonella spp., Shigella spp., Yersinia enterocolitica, Campylobacter, Streptococcus agalactiae, Staphylococcus aureus, enteropathogens Escherichia coli.
  • Subjects being treated with cyclosporine, mycophenolate or tacrolimus
  • Women who are pregnant or breastfeeding
  • Psychiatric conditions that reduce protocol compliance
  • Patients with IBD
  • Subjects \<18 years.
  • Subjects diagnosed with not determined colitis
  • Patients with significant comorbidities (sepsis, severe trauma within the last 4 weeks, NYHA class IV heart failure)
  • Patients with symptoms compatible with those caused by IBD, such as infectious colitis, irritable bowel syndrome, ischemic colitis, actinic colitis.
  • Subjects receiving or expected to receive cyclosporine, mycophenolate or tacrolimus within 4 weeks of the first day study visit.
  • Positivity for parasitological faeces culture for Giardia lamblia, Entamoeba histolytica / dispar, Cryptosporidium parvum and other parasites.
  • Positive faeces culture for C. difficile, Salmonella spp., Shigella spp., Yersinia enterocolitica, Campylobacter, Streptococcus agalactiae, Staphylococcus aureus, enteropathogens Escherichia coli.
  • Patients diagnosed with primary sclerosing cholangitis.
  • Women who are pregnant or breastfeeding.
  • Psychiatric conditions that reduce protocol compliance
  • Patients with IBS
  • Current or previous infectious diseases (HAV, HBV, HCV, HIV, Cytomegalovirus, Epstein-Barr virus)
  • Chronic liver disease
  • History of C. difficile infections
  • Recent (\<3 months) therapy with antibiotics, immunosuppressive drugs, chemotherapy
  • Chronic therapy with proton pump inhibitors
  • Previous history of organ / tissue transplantation
  • Previous gastrointestinal surgery (eg gastric bypass)
  • Recurrent urinary tract infections (3 cases per year)
  • Previous major acute cardiovascular diseases (myocardial infarction, stroke)
  • Type 2 diabetes mellitus
  • eGFR lower than 60ml / minute and / or diagnosis of nephropathy
  • Systemic inflammatory diseases
  • Suspicion, clinical diagnosis or previous history of cancer (\<5 years)
  • Autoimmune disorders or history of chronic and systemic autoimmune disorders
  • Neurodegenerative disorders
  • Pregnancy and breastfeeding
  • Psychiatric conditions that reduce protocol compliance.
  • Patients with hepatic encefalopathy
  • History of C. difficile infections
  • Chronic therapy with proton pump inhibitors
  • Previous history of organ / tissue transplantation
  • Recent emergence of diarrhea
  • Chronic diarrhea
  • 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
  • eGFR lower than 60ml / minute and / or diagnosis of nephropathy
  • Systemic inflammatory diseases
  • Suspicion, clinical diagnosis or previous history of cancer (\<5 years)
  • Autoimmune disorders or history of chronic and systemic autoimmune disorders
  • Pregnancy and breastfeeding
  • Psychiatric conditions that reduce protocol compliance

Exclusion

    Key Trial Info

    Start Date :

    February 8 2021

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    May 10 2022

    Estimated Enrollment :

    225 Patients enrolled

    Trial Details

    Trial ID

    NCT04698148

    Start Date

    February 8 2021

    End Date

    May 10 2022

    Last Update

    August 4 2022

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

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

    Bari, Italy

    2

    Università degli Studi di Perugia - Dipartimento di Medicina

    Perugia, Italy

    3

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

    Roma, Italy