Chronic Kidney Diseases, Healthy
Conditions
Keywords
gut microbiota dysbiosis, uremic toxins, symbiotic
Brief summary
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
Interventions
DIETARY_SUPPLEMENTSymbiotic
2-months oral administration of the symbiotic supplement (2 bags/day) + 1 month washout
DIETARY_SUPPLEMENTPlacebo
2-months oral administration of the placebo (2 bags/day) + 1 month washout
Sponsors
University of Bari Aldo Moro
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
CKD patients Inclusion Criteria: * CKD patients stage 3b-4 not on dialysis * Aged between 30 to 65 * BMI between 18.5 and 29.9 * Controlled diet * Informed consent signed
Exclusion criteria
* Type 2 diabetes mellitus * 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 * Previous acute cardiovascular diseases (myocardial infarction, stroke) * Psychiatric conditions reducing the compliance to treatment protocols Healthy volunteers Inclusion Criteria: * Healthy subjects * Aged between 35 to 60 * BMI between 18.5 and 29.9 * Medium score of adherence to Mediterranean Diet (PREDIMED score between 6 and 9) * Informed consent signed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of serum concentration of pCS | 3 months | 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 | 3 months | Change of D-lactate serum concentration (uM) |
| Change of serum concentration of LPS | 3 months | Change of lipopolysaccharide (LPS) serum concentration (EU/ml) |
| Change of percentage of sugar urinary recovery | 3 months | Change of percentage (%) of urinary recovery of 4 sugars (lactulose, mannitol, sucrose and sucralose) |
| Change of serum concentration of inflammatory markers | 3 months | Change of interleukin (IL)6, IL10, IL17, pentraxin3 (PTX3) serum concentrations (pg/ml) evaluated by ELISA |
| Change of serum concentration of NO | 3 months | Change of nitric oxide (NO) serum concentration (uM) evaluated by spectrometry |
| Change of serum concentration of IS | 3 months | Change of indoxyl sulfate (IS) serum concentrations assessed by liquid chromatography/mass spectrometry |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change of stool type | 3 months | 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 | 3 months | Change of trimethylamine-N-oxide (TMAO) serum concentrations assessed by liquid chromatography/mass spectrometry |
| Change of GI symptoms | 3 months | Change of gastrointestinal symptoms evaluated by Gastrointestinal Symptoms Rating Scale (GSRS) questionnaire (15 items scored 0-3 each, 0 representing the best and 3 the worse outcome for each item) |
| Gut microbiota | 3 months | 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