Establishment of the Human Intestinal and Salivary Microbiota Biobank – Kidney Diseases

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Brief Title

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

Official Title

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

Brief Summary

      This is a prospective, clinical, multicentre study aimed to collect biological samples and
      study microbiota from subjects suffering from chronic kidney disease 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 suffering from chronic renal diseases 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 chronic kidney disease (IgAN, ADPKD, advanced CKD and DKD), 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 150 subjects at Policlinic of Bari and University of Perugia, 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 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.

        -  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.

      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).

      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.
    


Study Type

Observational


Primary Outcome

Biological samples collection for establishment of the first National Microbiome Biobank


Condition

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Intervention

Biological sample collection

Study Arms / Comparison Groups

 ADPKD
Description:  Patients with ADPKD

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

150

Start Date

February 3, 2021

Completion Date

January 2022

Primary Completion Date

December 2021

Eligibility Criteria

        Inclusion Criteria:

        HEALTHY VOLUNTEERS

        Inclusion criteria:

          -  healthy subjects aged between 18 and 60 years

          -  BMI between 18.5-30

          -  omnivorous diet

          -  signature of the informed consent

        PATIENTS WITH ADPKD

        Inclusion criteria:

          -  subjects with ADPKD aged between 18 and 60 years

          -  creatinine clearance between 30mL / min and 60mL / min

          -  creatinine clearance > 60 mL / min

          -  BMI between 18.5-30

          -  omnivorous diet

          -  signature of the informed consent

        PATIENTS WITH ADVANCED CKD

        Inclusion criteria:

          -  subjects with advanced CDK (creatinine clearance <30 mL / min)

          -  age between 18 and 60 years

          -  BMI between 18.5-30

          -  omnivorous diet

          -  signature of the informed consent

        PATIENTS WITH IgAN

        Inclusion criteria:

          -  subjects with IgAN, "progressor" (who have an increase in proteinuria or creatininemia
             or reduction in eGFR within the previous three years)

          -  subjects with IgAN, "non progressor"

          -  creatinine clearance> 30 mL / min

          -  BMI between 18.5-30

          -  omnivorous diet

          -  signature of the informed consent

        PATIENTS WITH DKD

        Inclusion criteria:

          -  subjects with DKD

          -  subjects with A1, G1-3a staging

          -  subjects with A2, G1-3a staging

          -  subjects with staging A3, G1-3a

          -  creatinine clearance> 45 mL / min

          -  age between 18 and 60 years

          -  BMI between 18.5-30

          -  omnivorous diet

          -  signature of the 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 ADPKD; PATIENTS WITH ADVANCED CKD; PATIENTS WITH IgAN; PATIENTS WITH DKD

          -  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 emergence 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) occurred
             in the last 3 years

          -  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

          -  Type 2 diabetes mellitus

          -  Pregnancy and breastfeeding

          -  Psychiatric conditions that reduce protocol compliance.
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Loreto Gesualdo, MD, 0039-080-5592774, [email protected]; [email protected]

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT04689074

Organization ID

BIOMIS-Nefro


Responsible Party

Sponsor

Study Sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Collaborators

 Università degli Studi di Perugia

Study Sponsor

Loreto Gesualdo, MD, Principal Investigator, Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari


Verification Date

December 2020