Hemodialysis
Conditions
Keywords
uremic toxins, gut microbiota dysbiosis, symbiotic, divinylbenzene cartridge
Brief summary
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
Interventions
DIETARY_SUPPLEMENTSymbiotic
HD patients follow a 8-weeks oral administration of the symbiotic supplement (2 bags/day)
DIETARY_SUPPLEMENTPlacebo
HD patients follow a 8-weeks oral administration of the placebo (2 bags/day)
DEVICEDVB cartridge
On the last week of the symbiotic/placebo period, patients undergo 3 dialytic sessions with the DVB cartridge
Sponsors
University of Bari Aldo Moro
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of serum concentration of pCS | 8 weeks | Change of p-cresyl sulfate (pCS) serum concentrations assessed by liquid chromatography/mass spectrometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of serum concentration of D-lactate | 8 weeks | Change of D-lactate serum concentration (uM) |
| Change of serum concentration of IS | 8 weeks | Change of indoxyl sulfate (IS) serum concentrations assessed by liquid chromatography/mass spectrometry |
| Change of serum concentration of LPS | 8 weeks | Change of lipopolysaccharide (LPS) serum concentration (EU/ml) |
| Change of serum concentration of inflammatory markers | 8 weeks | Change of interleukin (IL)IL10, IL17, pentraxin3 (PTX3) serum concentrations (pg/ml) evaluated by ELISA |
| Change of serum concentration of NO | 8 weeks | Change of nitric oxide (NO) serum concentration (uM) evaluated by spectrometry |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change of stool type | 8 weeks | Change of stool type evaluated by BRISTOL Stool Scale (range 1-7, lower and higher values representing worse outcome, middle values representing better outcome) |
| Change of serum concentration of TMAO | 8 weeks | Change of trimethylamine-N-oxide (TMAO) serum concentrations assessed by liquid chromatography/mass spectrometry |
| Change of GI symptoms | 8 weeks | Change of gastrointestinal symptoms evaluated by Gastrointestinal Symptoms Rating Scale (GSRS) questionnaire (15 items scored 1-7 each, 1 representing the best and 7 the worse outcome for each item) |
| Gut microbiota | 8 weeks | Change of the relative abundance (%) of Operational Taxonomic Units (OTUs) of Firmicutes, Bacteroidetes,Proteobacteria, Verrucomicrobia, Actinobacteria, Synergistetes, Cyanobacteria, Euryarchaeota, Chloroflexi, Nitrospirae, Tenericutes, Fusobacteria, Thermotogae, Acidobacteria evaluated by fecal bacterial DNA genome sequencing. |
Countries
Italy
Outcome results
None listed