Clinical trial NCT05359094: Probiotic Supplements in Chronic Kidney Disease
Official title: To Explore the Effect of Probiotic Supplements in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Probiotics
Chronic kidney disease
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
Collaborators: name: Grape King Bio Ltd.
First posted: 2022-05-03
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Estimated glomerular filtration rate (eGFR) measurement
timeFrame: Baseline to 24 week
measure: Blood Urea Nitrogen (BUN) levels
timeFrame: Baseline to 24 week
measure: Electrolytes Analysis
timeFrame: Baseline to 24 week
Secondary outcomes:
measure: Uremic toxins assay
timeFrame: Baseline to 24 week
measure: Sugar test
timeFrame: Baseline to 24 week
measure: Nutrition status
timeFrame: Baseline to 24 week
measure: Inflammation makers
timeFrame: Baseline to 24 week
measure: Liver function
timeFrame: Baseline to 24 week
measure: Lipid analysis
timeFrame: Baseline to 24 week
measure: The quality of life
timeFrame: Baseline to 24 week
measure: Complete Blood Count (CBC) Test
timeFrame: Baseline to 24 week
measure: Urine Analysis
timeFrame: Baseline to 24 week
measure: 24-hour Dietary recall
timeFrame: Baseline to 24 week
measure: Safety and compliance
timeFrame: Baseline to 24 week
measure: Grip strength levels
timeFrame: Baseline to 24 week
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taiwan
state: ROC
Study officials:
affiliation: Division of Nephrology in Taichung Veterans General Hospital
name: Cheng-Hsu Chen, MDPHD
role: PRINCIPAL_INVESTIGATOR
References: