Increase the quality of life of patients with chronic kidney disease. Urological and Genital Diseases
Conditions
Interventions
To ameliorate the quality of life in chronic kidney disease (CKD) subjects, the use of dietary supplements has increased over time. Among those, curcumin has demonstrated significant in vitro anti-inf
collected stool samples to analyze gut microbiota composition.
Sponsors
University of Milan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients: 1. CKD from stage 3a to 4 (defined according to the GFR values of the KDOQI guide-lines), not being on hemodialysis treatment 2. Age = 18 years 3. Absence of: chronic infections, active neoplasm, vasculitis, autoimmune or acute inflammatory diseases, gastro-intestinal pathologies, dementia, steroid therapies, and pregnancy Healthy volunteers: 1. Age and sex-matched with CKD group 2. Absence of CKD or other kidney-related pathologies
Exclusion criteria
Exclusion criteria: All groups: Presence of: chronic infections, active neoplasm, vasculitis, autoimmune or acute inflammatory diseases, gastro-intestinal pathologies, dementia, steroid therapies, and pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Nutritional, inflammatory and oxidative status measured using 3-days food diary, bioimpedance, ELISA immunological test for eight cytokines/chemokines on plasma and lipoperoxidation levels on plasma (TBARS assay) at baseline, after 3 months and after 6 months 2. CKD progression measured using glomerular filtration rate (eGFR, CKD-EPI formula) at baseline, after 3 months and after 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Gut microbiota measured using Next Generation Sequencing (Ion 16S Metagenomics Kit) on DNA extracted from stool samples at baseline, after 3 months and after 6 months 2. Uremic toxins measured using mass spectrometry (LC-MS/MS) at baseline, after 3 months and after 6 months | — |
Countries
Italy
Outcome results
None listed