The objective of the pilot study is to validate the clinical use of an innovative symbiotic in patients with chronic kidney disease (CKD) stage 3b-4 and in healthy subjects. The study aims at evaluating the effects of a symbiotic, consisting of a mixture of probiotics (Lactobacilli and Bifidobacteria), prebiotics (fructooligosaccharides and inulin) and natural antioxidants (a mix of quercetin, resveratrol and proanthocyanidins), by achieving two objectives: 1. Reduction of the serum levels of microbiota-derived uremic toxins, involved in a variety of cardiovascular complications in CKD 2. Reduction of intestinal permeability, inflammatory markers and oxidative stress
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
2-months oral administration of the symbiotic supplement (2 bags/day) + 1 month washout
2-months oral administration of the placebo (2 bags/day) + 1 month washout
AUO Policlinico Consorziale
Bari, BA, Italy
Change of serum concentration of pCS
Change of p-cresyl sulfate (pCS) serum concentrations assessed by liquid chromatography/mass spectrometry
Time frame: 3 months
Change of serum concentration of IS
Change of indoxyl sulfate (IS) serum concentrations assessed by liquid chromatography/mass spectrometry
Time frame: 3 months
Change of serum concentration of D-lactate
Change of D-lactate serum concentration (uM)
Time frame: 3 months
Change of serum concentration of LPS
Change of lipopolysaccharide (LPS) serum concentration (EU/ml)
Time frame: 3 months
Change of percentage of sugar urinary recovery
Change of percentage (%) of urinary recovery of 4 sugars (lactulose, mannitol, sucrose and sucralose)
Time frame: 3 months
Change of serum concentration of inflammatory markers
Change of interleukin (IL)6, IL10, IL17, pentraxin3 (PTX3) serum concentrations (pg/ml) evaluated by ELISA
Time frame: 3 months
Change of serum concentration of NO
Change of nitric oxide (NO) serum concentration (uM) evaluated by spectrometry
Time frame: 3 months
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