Probiotics-addicted Low-protein Diet for Microbiota Modulation in Patients With Advanced Chronic Kidney Disease (ProLowCKD): a Protocol of Placebo-controlled Randomized Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Renal Failure Chronic
- Sponsor
- Probiotical S.p.A.
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change from baseline of the markers of cardiovascular diseases
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •age 18-80 years
- •GFR \< 20 ml/min/sqm
- •afferent to the outpatient clinic in the Nephrology and Dialysis Unit (Azienda Ospedaliero Universitaria Maggiore della Carità)
- •Drop out or
Exclusion Criteria
- •subject refusing to sign the informed consent
- •administration of prolonged antibacterial therapy
- •dialysis initiation
Outcomes
Primary Outcomes
Change from baseline of the markers of cardiovascular diseases
Time Frame: 5 months
Change from baseline of the serum concentration of Lp-PLA2 (nmol/ml/min)
Change from baseline of the microbial inflammatory uremic toxins
Time Frame: 5 months
Change from baseline of the serum concentration of PC (mcMOL) and IS (mcMOL), as markers of dysbiotic microbiota
Change from baseline of the markers of intestinal barrier permeability
Time Frame: 5 months
Change from baseline of the serum concentration of LPS (EU/ml)
Change from baseline of the microbial gut populations
Time Frame: 5 months
* Change from baseline of the concentration of proteolytic microbial groups (number of cells/gram of faeces); * Change from baseline of the concentration of saccharolytic microbial groups (number of cells/gram of faeces)
Secondary Outcomes
- Measurement of the urine protein excretion(5 months)
- Evaluation of the serum acid-base equilibrium(5 months)
- Evaluation of the renal function(5 months)
- Measurement of vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health (Quality of Life)(5 months)
- Evaluation of the anemia(5 months)
- Evaluation of the body composition(5 months)
- Quantification of serum inflammatory markers(5 months)