Clinical Trials Logo
  1. Home
  2. Renal Failure, Chronic
  3. NCT04204005

Probiotics and Low Protein Diet in Advanced Chronic Kidney Disease — ProLowCKD  

Renal Failure Chronic Clinical Trial

Official title:
Probiotics-addicted Low-protein Diet for Microbiota Modulation in Patients With Advanced Chronic Kidney Disease (ProLowCKD): a Protocol of Placebo-controlled Randomized Trial

Clinical Trial Summary

Here the investigators will perform a double-blinded randomized placebo-controlled clinical trial to evaluate the synergic effect of low protein diet and prebiotics in reducing the microbial inflammatory uremic toxins.

Clinical Trial Description

ProLowCKD is a single-centre, double-blind, placebo-controlled, randomised study. At enrolment (T0) participants were prescribed a LPD in addition to their ongoing pharmacological therapy and according to their comorbidities; after 2 months (T2) they were randomized in accordance to a 1:1 ratio to receive probiotics or placebo for other 3 months (T5) in addition to the continuation of LPD. Enrolled subjects are invited to assume two doses of probiotic/placebo for 1 month and 1 dose for 2 months. Randomization is 1:1 to receive odd- or even envelopes, according to the odd- or even registration number at enrolment. Neither the clinician nor the patient knows the content of the odd- and even envelopes. The evaluations will be performed according to the following schedule: at T0 nephrological evaluation and biochemical analysis, dietary counselling, illustration of protocol and signing of the informed consent, administration of the SF36 questionnaire, body composition evaluation by bioimpedentiometry. At T0, T2, T5: blood biochemical parameters: haemoglobin, urea, creatinine, mean urea and creatinine clearance, CKD and MDRD calculation, sodium, potassium, uric acid, calcium, phosphate, PTH, acid-base balance, CRP, albumin, PC, IS, Lp-PLA2, LPS; 24h-urine biochemical parameters: urea, creatinine, sodium, proteins; microbial stools analysis; clinical nephrological and dietitian evaluation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04204005
Study type Interventional
Source Probiotical S.p.A.
Contact
Status Completed
Phase N/A
Start date March 13, 2017
Completion date December 31, 2020
View Details
See also
  Status Clinical Trial Phase
Completed NCT03246984 - VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ N/A
Completed NCT05787080 - Massage, Oxidative and Antioxidant Enzymes in Hemodialysis Patients With Restless Legs Syndrome(RLS) N/A
Completed NCT05585268 - Electronic Decision Support for Deprescribing in Patients on Hemodialysis N/A
Completed NCT02332811 - An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic CKD Patients Phase 3
Withdrawn NCT03093740 - Direct-acting Antiviral Therapy to Prevent HCV Infection for HCV Positive Donor to HCV Negative Recipient Kidney Transplant Phase 4
Recruiting NCT04908345 - Methadone Anesthesia For Kidney Transplant Receptors Phase 3
Completed NCT05769686 - Laparoscopic Donor Nephrectomy Score, a New Scoring System for Preoperative Prediction of Difficulty of Laparoscopic Donor Nephrectomy
Completed NCT03949036 - Comparison of Two Different Preload Targets of Stroke Volume Variation During Kidney Transplantation N/A
Completed NCT03658876 - Predictors of Response to Iron and Erythropoietin Stimulating Agents Phase 4
Not yet recruiting NCT04377243 - Immunotherapy of Chronic Kidney Failure Phase 2
Active, not recruiting NCT05418816 - SelfWrap-Assisted Arteriovenous Fistulas N/A
Active, not recruiting NCT03436368 - Continuous Spinal Anesthesia in Renal Transplantation N/A
Recruiting NCT03778944 - Enhancing Renal Graft Function During Donor Anesthesia N/A
Recruiting NCT05521425 - Randomized Controlled Trial on 3D Printed Assistive Device for Continuous Ambulatory Peritoneal Dialysis N/A
Recruiting NCT05077163 - Patients With Acute Renal Failure During Severe COVID-19
Active, not recruiting NCT05381961 - Observational Study of BIS in Hemodialysis Patients
Completed NCT03781726 - Multi-center Study to Transplant Hepatitis-C Infected Kidneys Phase 4