Establishment of the Human Intestinal and Salivary Microbiota Biobank - Kidney Diseases
NCT ID: NCT04689074
Last Updated: 2022-08-01
Study Results
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Basic Information
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COMPLETED
150 participants
OBSERVATIONAL
2021-02-03
2022-05-10
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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ADPKD
Patients with ADPKD
Biological sample collection
Collection of faeces, urine, saliva, PBMC and blood for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening
Questionnaire
Anamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire
Medical examination
Blood pressure measurement, abdominal and thoracic physical examination
advanced CKD
Patients with advanced CKD
Biological sample collection
Collection of faeces, urine, saliva, PBMC and blood for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening
Questionnaire
Anamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire
Medical examination
Blood pressure measurement, abdominal and thoracic physical examination
DKD
Patients with DKD
Biological sample collection
Collection of faeces, urine, saliva, PBMC and blood for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening
Questionnaire
Anamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire
Medical examination
Blood pressure measurement, abdominal and thoracic physical examination
IgAN
Patients with IgAN
Biological sample collection
Collection of faeces, urine, saliva, PBMC and blood for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening
Questionnaire
Anamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire
Medical examination
Blood pressure measurement, abdominal and thoracic physical examination
Healthy volunteers
Healthy volunteers
Biological sample collection
Collection of faeces, urine, saliva, PBMC and blood for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening
Questionnaire
Anamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire
Medical examination
Blood pressure measurement, abdominal and thoracic physical examination
Interventions
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Biological sample collection
Collection of faeces, urine, saliva, PBMC and blood for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening
Questionnaire
Anamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire
Medical examination
Blood pressure measurement, abdominal and thoracic physical examination
Eligibility Criteria
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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
* 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
* 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
* 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
* 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
* 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.
18 Years
60 Years
ALL
Yes
Sponsors
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University Of Perugia
OTHER
Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies
OTHER
Istituti Tumori Giovanni Paolo II
NETWORK
University of Salento
OTHER
University of Bari Aldo Moro
OTHER
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
OTHER
Responsible Party
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Principal Investigators
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Loreto Gesualdo, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
Locations
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Nefrologia, Dialisi e Trapianto di Rene - Dipartimento dell'emergenza e dei trapianti d'organo (DETO) - Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
Bari, , Italy
Sezione Medicina Interna e Scienze Endocrine e Metaboliche - (MISEM) - Università degli Studi di Perugia
Perugia, , Italy
Countries
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References
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Zhou Y, Xu H, Huang H, Li Y, Chen H, He J, Du Y, Chen Y, Zhou Y, Nie Y. Are There Potential Applications of Fecal Microbiota Transplantation beyond Intestinal Disorders? Biomed Res Int. 2019 Jul 29;2019:3469754. doi: 10.1155/2019/3469754. eCollection 2019.
Cosola C, Rocchetti MT, Sabatino A, Fiaccadori E, Di Iorio BR, Gesualdo L. Microbiota issue in CKD: how promising are gut-targeted approaches? J Nephrol. 2019 Feb;32(1):27-37. doi: 10.1007/s40620-018-0516-0. Epub 2018 Aug 1.
Castillo-Rodriguez E, Fernandez-Prado R, Esteras R, Perez-Gomez MV, Gracia-Iguacel C, Fernandez-Fernandez B, Kanbay M, Tejedor A, Lazaro A, Ruiz-Ortega M, Gonzalez-Parra E, Sanz AB, Ortiz A, Sanchez-Nino MD. Impact of Altered Intestinal Microbiota on Chronic Kidney Disease Progression. Toxins (Basel). 2018 Jul 19;10(7):300. doi: 10.3390/toxins10070300.
Kanbay M, Onal EM, Afsar B, Dagel T, Yerlikaya A, Covic A, Vaziri ND. The crosstalk of gut microbiota and chronic kidney disease: role of inflammation, proteinuria, hypertension, and diabetes mellitus. Int Urol Nephrol. 2018 Aug;50(8):1453-1466. doi: 10.1007/s11255-018-1873-2. Epub 2018 May 4.
Ramezani A, Massy ZA, Meijers B, Evenepoel P, Vanholder R, Raj DS. Role of the Gut Microbiome in Uremia: A Potential Therapeutic Target. Am J Kidney Dis. 2016 Mar;67(3):483-98. doi: 10.1053/j.ajkd.2015.09.027. Epub 2015 Nov 15.
Other Identifiers
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BIOMIS-Nefro
Identifier Type: -
Identifier Source: org_study_id
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