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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
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