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| Name | Class |
|---|---|
| Grape King Bio Ltd. | INDUSTRY |
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This research will investigate the effect of oral probiotic supplements on renal function, uremic toxins inflammatory response, nutrition status, gastrointestinal symptoms, and QoL with Chronic kidney disease.
Chronic kidney disease (CKD) with gut microbiota was different from a normal person. Some gut microbiota produces short-chain fatty acids or induces functional enzymes beneficial to patients. On the other hand, some gut microbiota may also metabolize amino acids into p-cresol and indole which were leading to the accumulation of urinary toxins and damage to the kidney. This research will investigate the effect of oral probiotic supplements on renal function, uremic toxins, inflammatory response, nutrition status, gastrointestinal symptoms, and QoL with CKD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| Probiotics | Active Comparator | Probiotics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Placebo (Microcrystalline α-cellulose) supplement with a Plant-Dominant Low-Protein Diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimated glomerular filtration rate (eGFR) measurement | The eGFR level is a maker for kidney function | Baseline to 24 week |
| Blood Urea Nitrogen (BUN) levels | Blood Urea Nitrogen | Baseline to 24 week |
| Electrolytes Analysis | The concentration of electrolytes analysis in the subject's blood samples | Baseline to 24 week |
| Measure | Description | Time Frame |
|---|---|---|
| Uremic toxins assay | The concentration of p-cresol sulfate level, indoxyl sulfates level, and trimethylamine N-oxide level (TMAO) in the subjects' blood samples | Baseline to 24 week |
| Sugar test |
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Inclusion criteria:
Exclusion criteria::
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| Name | Affiliation | Role |
|---|---|---|
| Cheng-Hsu Chen, MDPHD | Division of Nephrology in Taichung Veterans General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taiwan | Taichung | ROC | 40705 | Taiwan |
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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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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Probiotics | Dietary Supplement | Probiotics(Pediococcus acidilactici GKA4) supplement with a Plant-Dominant Low-Protein Diet |
|
The concentration of fasting sugar and HbA1C in the subjects' blood samples
| Baseline to 24 week |
| Nutrition status | The concentration of albumin,TIBC,TFS and uric acid in the subjects' blood samples | Baseline to 24 week |
| Inflammation makers | The concentration of inflammation makers in the subjects' blood samples | Baseline to 24 week |
| Liver function | The concentration of ALT and AST in the subjects' blood samples | Baseline to 24 week |
| Lipid analysis | The concentration of total cholesterol , triglyceride , HDL-cholesterol and LDL-cholesterol in the subjects' blood samples | Baseline to 24 week |
| The quality of life | Health-related quality of life was measured by 5-level EQ-5D questionnaire | Baseline to 24 week |
| Complete Blood Count (CBC) Test | The concentration of CBC test in the subject's blood samples | Baseline to 24 week |
| Urine Analysis | Urine specimen collection will be evaluate such as urine routine ,bacteria, protein and MCP-1. | Baseline to 24 week |
| 24-hour Dietary recall | There will be collected by food models or a photography atlas to estimate portion size. | Baseline to 24 week |
| Safety and compliance | Gastrointestinal symptoms measured by questionnaire | Baseline to 24 week |
| Grip strength levels | Hand grip strength was measured by grip strength device | Baseline to 24 week |
| 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 |
| D019602 |
| Food and Beverages |