Status:
COMPLETED
Establishment of the Human Intestinal and Salivary Microbiota Biobank - Kidney Diseases
Lead Sponsor:
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Collaborating Sponsors:
University Of Perugia
Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies
Conditions:
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Advanced-Chronic Kidney Disease (CKD)
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 suffering from chronic kidney disease and from healthy volunteers. 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 kid...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 3 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 10 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04689074
Start Date
February 3 2021
End Date
May 10 2022
Last Update
August 1 2022
Active Locations (2)
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1
Nefrologia, Dialisi e Trapianto di Rene - Dipartimento dell'emergenza e dei trapianti d'organo (DETO) - Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
Bari, Italy
2
Sezione Medicina Interna e Scienze Endocrine e Metaboliche - (MISEM) - Università degli Studi di Perugia
Perugia, Italy