Probiotic Supplements in Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

To Explore the Effect of Probiotic Supplements in Chronic Kidney Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05359094
• Other study ID #: SF22054A
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: Taichung Veterans General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Placebo
Placebo (Microcrystalline a-cellulose) supplement with a Plant-Dominant Low-Protein Diet
• Probiotics
Probiotics(Pediococcus acidilactici GKA4) supplement with a Plant-Dominant Low-Protein Diet

Locations

Country	Name	City	State
Taiwan	Taiwan	Taichung	ROC

Sponsors (2)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital	Grape King Bio Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

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