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Clinical Trials/NCT05359094
NCT05359094CompletedNot Applicable

To Explore the Effect of Probiotic Supplements in Chronic Kidney Disease

Taichung Veterans General Hospital2 sites in 1 country80 target enrollmentStarted: June 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
80
Locations
2
Primary Endpoint
Blood Urea Nitrogen (BUN) levels

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Blood Urea Nitrogen (BUN) levels

Time Frame: Baseline to 24 week

Blood Urea Nitrogen

Estimated glomerular filtration rate (eGFR) measurement

Time Frame: Baseline to 24 week

The eGFR level is a maker for kidney function

Electrolytes Analysis

Time Frame: Baseline to 24 week

The concentration of electrolytes analysis in the subject's blood samples

Secondary Outcomes

  • Lipid analysis(Baseline to 24 week)
  • 24-hour Dietary recall(Baseline to 24 week)
  • The quality of life(Baseline to 24 week)
  • Complete Blood Count (CBC) Test(Baseline to 24 week)
  • Uremic toxins assay(Baseline to 24 week)
  • Sugar test(Baseline to 24 week)
  • Inflammation makers(Baseline to 24 week)
  • Urine Analysis(Baseline to 24 week)
  • Safety and compliance(Baseline to 24 week)
  • Grip strength levels(Baseline to 24 week)
  • Nutrition status(Baseline to 24 week)
  • Liver function(Baseline to 24 week)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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