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

NCT04689074 | Completed

• 1 other identifier: BIOMIS-Nefro
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD); Advanced-Chronic Kidney Disease (CKD); Diabetic Kidney Disease (DKD); IgA Nephropathy (IgAN)

Keywords

Microbioma biobank; Biological human samples; Chronic kidney diseases; Meta-omics approaches; Microbiota-pathology relationship

Outcome Measures

Primary Outcomes (1)

• Biological samples collection for establishment of the first National Microbiome Biobank

  Recruitment of 150 subjects (ADPKD, advanced CDK, DKD, IgAN patients and healthy volunteers) to collect biological samples for establishment of the first National Microbiome Biobank

  through study completion, an average of 1 year

Study Arms (5)

ADPKD

Patients with ADPKD

Other: Biological sample collection; Other: Questionnaire; Other: Medical examination

advanced CKD

Patients with advanced CKD

Other: Biological sample collection; Other: Questionnaire; Other: Medical examination

DKD

Patients with DKD

Other: Biological sample collection; Other: Questionnaire; Other: Medical examination

IgAN

Patients with IgAN

Other: Biological sample collection; Other: Questionnaire; Other: Medical examination

Healthy volunteers

Healthy volunteers

Other: Biological sample collection; Other: Questionnaire; Other: Medical examination

Interventions

Biological sample collection OTHER

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

ADPKD; DKD; Healthy volunteers; IgAN; advanced CKD

Questionnaire OTHER

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

ADPKD; DKD; Healthy volunteers; IgAN; advanced CKD

Medical examination OTHER

Blood pressure measurement, abdominal and thoracic physical examination

ADPKD; DKD; Healthy volunteers; IgAN; advanced CKD

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of ADKD, advanced CDK, DKD and IgAN 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.

You may qualify if:

• HEALTHY VOLUNTEERS
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: lead
• University Of Perugia: collaborator
• Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies: collaborator
• Istituti Tumori Giovanni Paolo II: collaborator
• University of Salento: collaborator
• University of Bari Aldo Moro: collaborator

Study Sites (2)

Nefrologia, Dialisi e Trapianto di Rene - Dipartimento dell'emergenza e dei trapianti d'organo (DETO) - Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari

Bari, Italy

Location

Sezione Medicina Interna e Scienze Endocrine e Metaboliche - (MISEM) - Università degli Studi di Perugia

Perugia, Italy

Location

Related Publications (5)

• 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.

  PMID: 31467881 BACKGROUND

• 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.

  PMID: 30069677 BACKGROUND

• 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.

  PMID: 30029499 BACKGROUND

• 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.

  PMID: 29728993 BACKGROUND

• 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.

  PMID: 26590448 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

faeces, saliva, blood, serum, urine, PBMC

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant; Diabetic Nephropathies; Glomerulonephritis, IGA; Renal Insufficiency, Chronic

Interventions

Surveys and Questionnaires; Independent Medical Evaluation

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glomerulonephritis; Nephritis; Autoimmune Diseases; Immune System Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Loreto Gesualdo, MD

  Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 30, 2020
• Study Start: February 3, 2021
• Primary Completion: May 10, 2022
• Study Completion: May 10, 2022
• Last Updated: August 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)