NATURE 3.2_New Approach for the Reduction of REnal Uremic Toxins

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari16 enrolled

Overview

The objective of the pilot study is to validate a combined approach based on the use of an innovative symbiotic and an innovative dialysis cartridge in patients on hemodialysis (HD). The symbiotic consists of a mixture of probiotics (Lactobacilli and Bifidobacteria), prebiotics (fructoligosaccharides and inulin) and natural antioxidants (a mix of quercetin, resveratrol and proanthocyanidins). The cartridge is composed of a divinylbenzene (DVB) adsorbing resine, expected to have high affinity to protein-bound uremic toxins pCS and IS, on the basis of its chemical structure. This combined approach will be aimed at achieving two main objectives: 1. reduction of blood levels of microbial-derived uremic toxins, involved in cardiovascular complications 2. reduction of inflammation markers and oxidative stress and reduction of intestinal permeability

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hemodialysis

Interventions

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * CKD patients on bicarbonate hemodialysis * Aged between 30 to 65 * BMI between 18.5 and 29.9 * Omnivore diet * Informed consent signed Exclusion Criteria: * Use of antibiotics or probiotics up to 30 days prior to recruitment * Chronic gastrointestinal disorders * Systemic inflammatory diseases * Suspicion or clinical diagnosis of malignancy * Chronic liver disease * Treatment with corticosteroids or immunosuppressive drugs * Psychiatric conditions reducing the compliance to treatment protocols

Outcomes

Primary Outcomes

Change of serum concentration of pCS

Change of p-cresyl sulfate (pCS) serum concentrations assessed by liquid chromatography/mass spectrometry

Time frame: 8 weeks

Secondary Outcomes

Change of serum concentration of IS

Change of indoxyl sulfate (IS) serum concentrations assessed by liquid chromatography/mass spectrometry

Time frame: 8 weeks

Change of serum concentration of D-lactate

Change of D-lactate serum concentration (uM)

Time frame: 8 weeks

Change of serum concentration of LPS

Change of lipopolysaccharide (LPS) serum concentration (EU/ml)

Time frame: 8 weeks

Change of serum concentration of inflammatory markers

Change of interleukin (IL)IL10, IL17, pentraxin3 (PTX3) serum concentrations (pg/ml) evaluated by ELISA

Time frame: 8 weeks

Change of serum concentration of NO

Change of nitric oxide (NO) serum concentration (uM) evaluated by spectrometry

Time frame: 8 weeks

NATURE 3.2_New Approach for the Reduction of REnal Uremic Toxins

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes