Probiotic Supplements in Chronic Kidney Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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To Explore the Effect of Probiotic Supplements in Chronic Kidney Disease

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Probiotics


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Aged over 20 years old. Patients with 2 3a stage chronic kidney disease. Those who can cooperate with the research plan for 3 visits and retain samples (blood, urine). Exclusion criteria:: Use of other probiotics during the study. Those with active infectious diseases in the past month. Those who have used antibiotics within the past 1 month or during the study. Women who are pregnant or breastfeeding. Obstructive nephropathy within the past month. Polycystic kidney disease (polycystic kidney disease). Acute kidney disease within the past 3 months. Gastrointestinal bleeding within the past 3 months. Malignancy. Severe cardiovascular disease (cardiovascular disease) in the past 3 months, such as coronary artery disease (coronary artery disease), myocardial ischemia (myocardial ischemia), NYHA class IV myocardial failure, cerebrovascular disease, or peripheral artery disease.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: Placebo<br>* Placebo (Microcrystalline α-cellulose) supplement with a Plant-Dominant Low-Protein Diet<br>|
| Active Comparator: Probiotics<br>Probiotics | Dietary Supplement: Probiotics<br>* Probiotics(Pediococcus acidilactici GKA4) supplement with a Plant-Dominant Low-Protein Diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, Chronic kidney disease