Probiotic Supplements in Chronic Kidney Disease

To Explore the Effect of Probiotic Supplements in Chronic Kidney Disease

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotics

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • ROC
    • Taichung, ROC, Taiwan, 40705
      • Taiwan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

1. Aged over 20 years old.
2. Patients with 2~3a stage chronic kidney disease.
3. Those who can cooperate with the research plan for 3 visits and retain samples (blood, urine).

Exclusion criteria::

1. Use of other probiotics during the study.
2. Those with active infectious diseases in the past month.
3. Those who have used antibiotics within the past 1 month or during the study.
4. Women who are pregnant or breastfeeding.
5. Obstructive nephropathy within the past month.
6. Polycystic kidney disease (polycystic kidney disease).
7. Acute kidney disease within the past 3 months.
8. Gastrointestinal bleeding within the past 3 months.
9. Malignancy.
10. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
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
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
Inflammation makers	The concentration of inflammation makers 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

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital
• Collaborators: Grape King Bio Ltd.
• Investigators: Principal Investigator: Cheng-Hsu Chen, MDPHD, Division of Nephrology in Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): August 8, 2023
• Study Completion (Actual): July 15, 2024

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 19, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Probiotics; Chronic kidney disease
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: SF22054A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No