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Clostridium Difficile InfectionBIOMIS-GastrNCT04698148

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

An observational study of Clostridium Difficile Infection and Multi Drug Resistant Organisms, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 3 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
What is being tested?
Biological sample collection, Questionnaire and Medical examination
How many people
225 participants
Where
3 sitesItaly
Study dates
8 Feb 2021to 10 May 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

3 sites in 1 country.

Italy3 sites

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

    Bari

  • Università degli Studi di Perugia - Dipartimento di Medicina

    Perugia

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

    Roma

Other trials in Italy

About this study

Official title: Costituzione Della Biobanca Del Microbiota Intestinale e Salivare Umano: Dalla Disbiosi Alla Simbiosi

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.
Read the 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.

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.

Being tested
Biological sample collection, Questionnaire, Medical examination
Keywords
Microbioma biobank, Biological human samples, Gastrointestinal disease, Meta-omics approaches, Microbiota-pathology relationship
Medical subject headings
Clostridium Infections, Irritable Bowel Syndrome, Hepatic Encephalopathy, Gastrointestinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biological sample collectionOther

    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

  • QuestionnaireOther

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

  • Medical examinationOther

    Blood pressure measurement, abdominal and thoracic physical examination

Study groups in NCT04698148
Study groupRoleWhat they receive
CDI patientsPatients with Clostridium Difficile Infection
Receives: Other: Biological sample collection; Other: Questionnaire; Other: Medical examination
MDRO patientsPatients with Multi Drug Resistant Organisms infection
Receives: Other: Biological sample collection; Other: Questionnaire; Other: Medical examination
IBD patientsPatients with Chronic Inflammatory Bowel Disease
Receives: Other: Biological sample collection; Other: Questionnaire; Other: Medical examination
IBS patientsPatients with Irritable Bowel Syndrome
Receives: Other: Biological sample collection; Other: Questionnaire; Other: Medical examination
Hepatic Encephalopathy patientsPatients with Hepatic Encephalopathy
Receives: Other: Biological sample collection; Other: Questionnaire; Other: Medical examination
healthy volunteershealthy volunteers
Receives: Other: Biological sample collection; Other: Questionnaire; Other: Medical examination

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2021
  2. Study start8 Feb 2021
  3. Primary completion10 May 2022
  4. Study completion10 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
225 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04698148
Sponsor's protocol ID
BIOMIS-Gastr
Acronym
BIOMIS-Gastr
Status last verified
Jan 2022
First submitted
17 Dec 2020
Last updated
4 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31654298

  • 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.

    PubMed 32065881

  • 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.

    PubMed 31468999

  • 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.

    PubMed 28743984

  • 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.

    PubMed 25623659

Questions about this trial

What is this clinical trial studying?

An observational study of Clostridium Difficile Infection and Multi Drug Resistant Organisms, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 37 inclusion and 92 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biological samples collection for establishment of the first National Microbiome Biobank (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04698148, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.

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