Probiotic Supplements in Chronic Kidney Disease

Not Applicable

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Probiotics

• Registration Number: NCT05359094
• Lead Sponsor: Taichung Veterans General Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-04-27
• Study First Submitted QC: 2022-04-27
• Study First Posted: 2022-05-03
• Study Start: 2022-06-01
• Status Verified: 2023-03
• Primary Completion: 2023-08-08
• Study Completion: 2024-07-15
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Probiotics	Probiotics	Probiotics

Primary Outcome Measures

Name	Time	Method
Blood Urea Nitrogen (BUN) levels	Baseline to 24 week	Blood Urea Nitrogen
Estimated glomerular filtration rate (eGFR) measurement	Baseline to 24 week	The eGFR level is a maker for kidney function
Electrolytes Analysis	Baseline to 24 week	The concentration of electrolytes analysis in the subject's blood samples

Secondary Outcome Measures

Name	Time	Method
Lipid analysis	Baseline to 24 week	The concentration of total cholesterol , triglyceride , HDL-cholesterol and LDL-cholesterol in the subjects' blood samples
24-hour Dietary recall	Baseline to 24 week	There will be collected by food models or a photography atlas to estimate portion size.
The quality of life	Baseline to 24 week	Health-related quality of life was measured by 5-level EQ-5D questionnaire
Complete Blood Count (CBC) Test	Baseline to 24 week	The concentration of CBC test in the subject's blood samples
Uremic toxins assay	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
Sugar test	Baseline to 24 week	The concentration of fasting sugar and HbA1C in the subjects' blood samples
Inflammation makers	Baseline to 24 week	The concentration of inflammation makers in the subjects' blood samples
Urine Analysis	Baseline to 24 week	Urine specimen collection will be evaluate such as urine routine ,bacteria, protein and MCP-1.
Safety and compliance	Baseline to 24 week	Gastrointestinal symptoms measured by questionnaire
Grip strength levels	Baseline to 24 week	Hand grip strength was measured by grip strength device
Nutrition status	Baseline to 24 week	The concentration of albumin,TIBC,TFS and uric acid in the subjects' blood samples
Liver function	Baseline to 24 week	The concentration of ALT and AST in the subjects' blood samples

Trial Locations

Locations (1)

Taiwan; 🇨🇳 Taichung, ROC, Taiwan