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| Name | Class |
|---|---|
| University of Bari Aldo Moro | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symbiotic | Experimental | HD patients with 7 weeks symbiotic administration + 1 week overlapping with the 3 dialytic sessions with the DVB cartridge |
|
| Placebo | Placebo Comparator | HD patients with 7 weeks placebo administration + 1 week overlapping with the 3 dialytic sessions with the DVB cartridge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symbiotic | Dietary Supplement | HD patients follow a 8-weeks oral administration of the symbiotic supplement (2 bags/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of serum concentration of pCS | Change of p-cresyl sulfate (pCS) serum concentrations assessed by liquid chromatography/mass spectrometry | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of serum concentration of IS | Change of indoxyl sulfate (IS) serum concentrations assessed by liquid chromatography/mass spectrometry | 8 weeks |
| Change of serum concentration of D-lactate |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiota | 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. | 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Loreto Gesualdo, MD Full Prof | Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOUConsorziale Policlinico Di Bari | Bari | 70124 | Italy |
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| Placebo | Dietary Supplement | HD patients follow a 8-weeks oral administration of the placebo (2 bags/day) |
|
| DVB cartridge | Device | On the last week of the symbiotic/placebo period, patients undergo 3 dialytic sessions with the DVB cartridge |
|
Change of D-lactate serum concentration (uM)
| 8 weeks |
| Change of serum concentration of LPS | Change of lipopolysaccharide (LPS) serum concentration (EU/ml) | 8 weeks |
| Change of serum concentration of inflammatory markers | Change of interleukin (IL)IL10, IL17, pentraxin3 (PTX3) serum concentrations (pg/ml) evaluated by ELISA | 8 weeks |
| Change of serum concentration of NO | Change of nitric oxide (NO) serum concentration (uM) evaluated by spectrometry | 8 weeks |
| Change of GI symptoms | 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) | 8 weeks |
| Change of stool type | Change of stool type evaluated by BRISTOL Stool Scale (range 1-7, lower and higher values representing worse outcome, middle values representing better outcome) | 8 weeks |
| Change of serum concentration of TMAO | Change of trimethylamine-N-oxide (TMAO) serum concentrations assessed by liquid chromatography/mass spectrometry | 8 weeks |