Autosomal Dominant Polycystic Kidney Disease (ADPKD) Clinical Trial
— BIOMIS-NefroOfficial title:
Costituzione Della Biobanca Del Microbiota Intestinale e Salivare Umano: Dalla Disbiosi Alla Simbiosi
NCT number | NCT04689074 |
Other study ID # | BIOMIS-Nefro |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 3, 2021 |
Est. completion date | May 10, 2022 |
Verified date | January 2022 |
Source | Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | May 10, 2022 |
Est. primary completion date | May 10, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | 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 |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari | Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies, Istituti Tumori Giovanni Paolo II, Università degli Studi di Perugia, University of Bari Aldo Moro, University of Salento |
Italy,
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-Niño MD. Impact of Altered Intestinal Microbiota on Chronic Kidney Disease Progression. Toxins (Basel). 2018 Jul 19;10(7). pii: E300. doi: 10.3390/toxins10070300. Review. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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