Taiwan
Taichung, ROC, 40705, Taiwan
NCT Number: NCT05359094
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.
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Notify Me20 year and older
All sexes
Interventional
Not applicable
Taichung, ROC, 40705, Taiwan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
:
Placebo (Microcrystalline α-cellulose) supplement with a Plant-Dominant Low-Protein Diet
Probiotics(Pediococcus acidilactici GKA4) supplement with a Plant-Dominant Low-Protein Diet
Time frame: Baseline to 24 week
The eGFR level is a maker for kidney function
Time frame: Baseline to 24 week
Blood Urea Nitrogen
Time frame: Baseline to 24 week
The concentration of electrolytes analysis in the subject's blood samples
Time frame: Baseline to 24 week
The concentration of p-cresol sulfate level, indoxyl sulfates level, and trimethylamine N-oxide level (TMAO) in the subjects' blood samples
Time frame: Baseline to 24 week
The concentration of fasting sugar and HbA1C in the subjects' blood samples
Time frame: Baseline to 24 week
The concentration of albumin,TIBC,TFS and uric acid in the subjects' blood samples
Time frame: Baseline to 24 week
The concentration of inflammation makers in the subjects' blood samples
Time frame: Baseline to 24 week
The concentration of ALT and AST in the subjects' blood samples
Time frame: Baseline to 24 week
The concentration of total cholesterol , triglyceride , HDL-cholesterol and LDL-cholesterol in the subjects' blood samples
Time frame: Baseline to 24 week
Health-related quality of life was measured by 5-level EQ-5D questionnaire
Time frame: Baseline to 24 week
The concentration of CBC test in the subject's blood samples
Time frame: Baseline to 24 week
Urine specimen collection will be evaluate such as urine routine ,bacteria, protein and MCP-1.
Time frame: Baseline to 24 week
There will be collected by food models or a photography atlas to estimate portion size.
Time frame: Baseline to 24 week
Gastrointestinal symptoms measured by questionnaire
Time frame: Baseline to 24 week
Hand grip strength was measured by grip strength device
Taichung Veterans General Hospital
Other
To Explore the Effect of Probiotic Supplements in Chronic Kidney Disease
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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