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Probiotic Supplements in Chronic Kidney Disease

Primary Purpose

Chronic Kidney Disease

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Placebo
Probiotics
Sponsored by
Taichung Veterans General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Kidney Disease focused on measuring Probiotics, Chronic kidney disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Taiwan

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Probiotics

Arm Description

Placebo

Probiotics

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 27, 2022
Last Updated
March 24, 2023
Sponsor
Taichung Veterans General Hospital
Collaborators
Grape King Bio Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05359094
Brief Title
Probiotic Supplements in Chronic Kidney Disease
Official Title
To Explore the Effect of Probiotic Supplements in Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taichung Veterans General Hospital
Collaborators
Grape King Bio Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Probiotics, Chronic kidney disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Probiotics
Arm Type
Active Comparator
Arm Description
Probiotics
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo (Microcrystalline α-cellulose) supplement with a Plant-Dominant Low-Protein Diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics
Intervention Description
Probiotics(Pediococcus acidilactici GKA4) supplement with a Plant-Dominant Low-Protein Diet
Primary Outcome Measure Information:
Title
Estimated glomerular filtration rate (eGFR) measurement
Description
The eGFR level is a maker for kidney function
Time Frame
Baseline to 24 week
Title
Blood Urea Nitrogen (BUN) levels
Description
Blood Urea Nitrogen
Time Frame
Baseline to 24 week
Title
Electrolytes Analysis
Description
The concentration of electrolytes analysis in the subject's blood samples
Time Frame
Baseline to 24 week
Secondary Outcome Measure Information:
Title
Uremic toxins assay
Description
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
Title
Sugar test
Description
The concentration of fasting sugar and HbA1C in the subjects' blood samples
Time Frame
Baseline to 24 week
Title
Nutrition status
Description
The concentration of albumin,TIBC,TFS and uric acid in the subjects' blood samples
Time Frame
Baseline to 24 week
Title
Inflammation makers
Description
The concentration of inflammation makers in the subjects' blood samples
Time Frame
Baseline to 24 week
Title
Liver function
Description
The concentration of ALT and AST in the subjects' blood samples
Time Frame
Baseline to 24 week
Title
Lipid analysis
Description
The concentration of total cholesterol , triglyceride , HDL-cholesterol and LDL-cholesterol in the subjects' blood samples
Time Frame
Baseline to 24 week
Title
The quality of life
Description
Health-related quality of life was measured by 5-level EQ-5D questionnaire
Time Frame
Baseline to 24 week
Title
Complete Blood Count (CBC) Test
Description
The concentration of CBC test in the subject's blood samples
Time Frame
Baseline to 24 week
Title
Urine Analysis
Description
Urine specimen collection will be evaluate such as urine routine ,bacteria, protein and MCP-1.
Time Frame
Baseline to 24 week
Title
24-hour Dietary recall
Description
There will be collected by food models or a photography atlas to estimate portion size.
Time Frame
Baseline to 24 week
Title
Safety and compliance
Description
Gastrointestinal symptoms measured by questionnaire
Time Frame
Baseline to 24 week
Title
Grip strength levels
Description
Hand grip strength was measured by grip strength device
Time Frame
Baseline to 24 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng-Hsu Chen, MDPHD
Organizational Affiliation
Division of Nephrology in Taichung Veterans General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taiwan
City
Taichung
State/Province
ROC
ZIP/Postal Code
40705
Country
Taiwan

12. IPD Sharing Statement

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Probiotic Supplements in Chronic Kidney Disease

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