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Completed

NCT Number: NCT05359094

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Dietary Supplement

Placebo (Microcrystalline α-cellulose) supplement with a Plant-Dominant Low-Protein Diet

Probiotics

Dietary Supplement

Probiotics(Pediococcus acidilactici GKA4) supplement with a Plant-Dominant Low-Protein Diet

Primary outcomes

  1. Estimated glomerular filtration rate (eGFR) measurement

    Time frame: Baseline to 24 week

    The eGFR level is a maker for kidney function

  2. Blood Urea Nitrogen (BUN) levels

    Time frame: Baseline to 24 week

    Blood Urea Nitrogen

  3. Electrolytes Analysis

    Time frame: Baseline to 24 week

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

Secondary outcomes

  1. Uremic toxins assay

    Time frame: 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

  2. Sugar test

    Time frame: Baseline to 24 week

    The concentration of fasting sugar and HbA1C in the subjects' blood samples

  3. Nutrition status

    Time frame: Baseline to 24 week

    The concentration of albumin,TIBC,TFS and uric acid in the subjects' blood samples

  4. Inflammation makers

    Time frame: Baseline to 24 week

    The concentration of inflammation makers in the subjects' blood samples

  5. Liver function

    Time frame: Baseline to 24 week

    The concentration of ALT and AST in the subjects' blood samples

  6. Lipid analysis

    Time frame: Baseline to 24 week

    The concentration of total cholesterol , triglyceride , HDL-cholesterol and LDL-cholesterol in the subjects' blood samples

  7. The quality of life

    Time frame: Baseline to 24 week

    Health-related quality of life was measured by 5-level EQ-5D questionnaire

  8. Complete Blood Count (CBC) Test

    Time frame: Baseline to 24 week

    The concentration of CBC test in the subject's blood samples

  9. Urine Analysis

    Time frame: Baseline to 24 week

    Urine specimen collection will be evaluate such as urine routine ,bacteria, protein and MCP-1.

  10. 24-hour Dietary recall

    Time frame: Baseline to 24 week

    There will be collected by food models or a photography atlas to estimate portion size.

  11. Safety and compliance

    Time frame: Baseline to 24 week

    Gastrointestinal symptoms measured by questionnaire

  12. Grip strength levels

    Time frame: Baseline to 24 week

    Hand grip strength was measured by grip strength device

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Collaborators

  • Grape King Bio Ltd.

Registry information

Official study title

To Explore the Effect of Probiotic Supplements in Chronic Kidney Disease

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 3, 2022
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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