The goal of this observational study is to investigate the alterations in gut microbiota and metabolites among patients with uric acid stones following the administration of potassium sodium hydrogen citrate. The main question it aims to predict the potential metabolic mechanism and therapeutic target of potassium sodium hydrogen citrate in treating uric acid stones through analysis of gut microbiota and metabolomics. The participants were required to undergo a 3-month drug intervention, providing blood, urine, and stool samples before and after treatment. No additional interventions were implemented for the subjects.
The objectives of this study were to investigate the association between the presence of bacterial genera and short-chain fatty acids (SCFAs) in stool, as well as biochemical elements in blood and urine, among patients with uric acid nephrolithiasis. The sensitivity difference of potassium sodium hydrogen citrate in treating uric acid kidney stones was examined through gut microbiota analysis and metabolomics to predict potential metabolic mechanisms and sensitive targets for treatment. Blood biochemistry, 24-hour urine composition analysis, and other indicators were collected from the subjects. Fecal samples were obtained for 16S ribosomal RNA sequencing to analyze the characteristics of gut microbiota in relation to blood and urine biochemical metabolism indicators. Subjects received treatment with potassium sodium hydrogen citrate granules for a duration of 3 months. Blood and urine biochemical indexes, fecal samples, 16S ribosomal RNA sequencing data, and short-chain fatty acid levels in fecal samples were collected before and after treatment. The care of the enrolled patients will not be subject to any intervention.
Study Type
OBSERVATIONAL
Enrollment
30
Medication: Potassium sodium hydrogen citrate granules (MADAUS GMBH, Germany, 2.5g/package). Method: Preprandial urine pH was monitored to maintain an effective range of 6.2 to 6.8. One package should be taken after breakfast, one after lunch, and two after dinner. If the pH falls below 6.2, a half-package dose should be added; if it exceeds 6.8, a half-package dose should be reduced accordingly. Oral medication will be administered for a duration of three months. Medication requirements: Abstain from alcohol and smoking during treatment period and avoid using any probiotics or drugs that lower uric acid levels.
Changshu Hospital Affiliated to Soochow University
Changshu, Jiangsu, China
RECRUITINGMaximum diameter of stone
The patients underwent pre- and post-drug intervention abdominal CT examinations, enabling determination of the stone's maximum diameter（mm） through analysis of CT images.
Time frame: From enrollment to the end of treatment at 3 months
Gut microbiota analysis
The fecal samples were collected pre- and post-intervention for the analysis of gut microbiota.
Time frame: From enrollment to the end of treatment at 3 months
Short chain fatty acid contents
The collection of fecal samples was conducted both pre- and post-intervention in order to assess the levels of short-chain fatty acids.
Time frame: From enrollment to the end of treatment at 3 months
Serum triglycerides
The peripheral venous blood was collected pre- and post-intervention, and the serum triglyceride level (mmol/L) was measured by automatic biochemical analyzer.
Time frame: From enrollment to the end of treatment at 3 months
Serum cholesterol
The peripheral venous blood was collected pre- and post-intervention, and the serum cholesterol level (mmol/L) was measured by automatic biochemical analyzer.
Time frame: From enrollment to the end of treatment at 3 months
Serum high density lipoprotein cholesterol
The peripheral venous blood was collected pre- and post-intervention, and the serum high density lipoprotein cholesterol level (mmol/L) was measured by automatic biochemical analyzer.
Time frame: From enrollment to the end of treatment at 3 months
Serum low density lipoprotein cholesterol
The peripheral venous blood was collected pre- and post-intervention, and the serum low density lipoprotein cholesterol level (mmol/L) was measured by automatic biochemical analyzer.
Time frame: From enrollment to the end of treatment at 3 months
Serum creatinine
The peripheral venous blood samples were collected from the subjects both before and after the intervention, and the serum creatinine levels（μmol/L） were measured by automatic biochemical analyzer.
Time frame: From enrollment to the end of treatment at 3 months
Serum uric acid
The peripheral venous blood samples were collected from the subjects both before and after the intervention, and the serum uric acid levels（μmol/L） were measured by automatic biochemical analyzer.
Time frame: From enrollment to the end of treatment at 3 months
Serum potassium
The peripheral venous blood samples were collected from the subjects both before and after the intervention, and the serum potassium levels（mmol/L） were measured by automatic biochemical analyzer.
Time frame: From enrollment to the end of treatment at 3 months
Serum magnesium
The peripheral venous blood samples were collected from the subjects both before and after the intervention, and the serum magnesium levels（mmol/L） were measured by automatic biochemical analyzer.
Time frame: From enrollment to the end of treatment at 3 months
Urine pH
The urine pH value was assessed by collecting mid-stream urine samples before and after the intervention by automatic biochemical analyzer.
Time frame: From enrollment to the end of treatment at 3 months
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