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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 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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD patients | Experimental | CKD patients stage 3b-4 will follow a 2-months supplementation of either symbiotic or placebo |
|
| Controls | Other | Healthy volunteers will follow a 2-months supplementation of either symbiotic or placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symbiotic | Dietary Supplement | 2-months oral administration of the symbiotic supplement (2 bags/day) + 1 month washout |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of serum concentration of pCS | Change of p-cresyl sulfate (pCS) serum concentrations assessed by liquid chromatography/mass spectrometry | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change of serum concentration of IS | Change of indoxyl sulfate (IS) serum concentrations assessed by liquid chromatography/mass spectrometry | 3 months |
| 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. | 3 months |
CKD patients
Inclusion Criteria:
Exclusion Criteria:
Healthy volunteers
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 |
|---|---|---|---|---|---|---|
| AUO Policlinico Consorziale | Bari | BA | 70125 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37396126 | Derived | Vacca M, Celano G, Calabrese FM, Rocchetti MT, Iacobellis I, Serale N, Calasso M, Gesualdo L, De Angelis M. In vivo evaluation of an innovative synbiotics on stage IIIb-IV chronic kidney disease patients. Front Nutr. 2023 Jun 15;10:1215836. doi: 10.3389/fnut.2023.1215836. eCollection 2023. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Placebo | Dietary Supplement | 2-months oral administration of the placebo (2 bags/day) + 1 month washout |
|
Change of D-lactate serum concentration (uM)
| 3 months |
| Change of serum concentration of LPS | Change of lipopolysaccharide (LPS) serum concentration (EU/ml) | 3 months |
| Change of percentage of sugar urinary recovery | Change of percentage (%) of urinary recovery of 4 sugars (lactulose, mannitol, sucrose and sucralose) | 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 | 3 months |
| Change of serum concentration of NO | Change of nitric oxide (NO) serum concentration (uM) evaluated by spectrometry | 3 months |
| Change of GI symptoms | 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) | 3 months |
| 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) | 3 months |
| Change of serum concentration of TMAO | Change of trimethylamine-N-oxide (TMAO) serum concentrations assessed by liquid chromatography/mass spectrometry | 3 months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |