Clinical trial NCT06118320: The Effective of Potassium Sodium Hydrogen Citrate in Treating Uric Acid Stones Using Gut Microbiota and Metabolomics.
Official title: The Clinical Study Utilizing Gut Microbiota and Metabolomics to Investigate the Efficacy of Potassium Sodium Hydrogen Citrate Therapy in the Treatment of Uric Acid Kidney Stones.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Uric Acid Stones
Keywords: gut microbiota
renal uric acid stone
16S rRNA
short chain fatty acid
potassium sodium hydrogen citrate
Lead sponsor: Changshu Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All stone patients were diagnosed using urologic ultrasonography, kidney-ureter-bladder (KUB) X-ray, or abdominal computed tomography (CT). Stone samples were obtained through ureteroscopic lithotripsy (URSL), percutaneous nephrolithotomy (PCNL), or extracorporeal shock wave lithotripsy (ESWL). Stones were analyzed using an automated infrared spectroscopy system, LIIR-20 (Lanmode Scientific Instrument Co., Ltd., Tianjin, China), and the main components were determined based on the most abundant substances listed in the report, which were classified as pure or mixed uric acid stones (anhydrous uric acid content \>50%).

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

All stone patients were diagnosed using urologic ultrasonography, kidney-ureter-bladder (KUB) X-ray, or abdominal computed tomography (CT). Stone samples were obtained through ureteroscopic lithotripsy (URSL), percutaneous nephrolithotomy (PCNL), or extracorporeal shock wave lithotripsy (ESWL). Stones were analyzed using an automated infrared spectroscopy system, LIIR-20 (Lanmode Scientific Instrument Co., Ltd., Tianjin, China), and the main components were determined based on the most abundant substances listed in the report, which were classified as pure or mixed uric acid stones (anhydrous uric acid content \>50%).

Exclusion Criteria:

Patients with malignancy, chronic liver insufficiency, a history of statin use, and thyroid or parathyroid disease were excluded from the study. Similarly, individuals with a history of urolithiasis or dyslipidemia as well as those who had used statins were excluded from the control group. Participants were also excluded if they had taken antibiotics or immune suppressants within one month prior to fecal sampling, or had a history of chronic diarrhea or constipation, chronic enteritis, irritable bowel syndrome, gastrointestinal tumors or intestinal surgery.

Primary outcomes:
measure: Maximum diameter of stone
timeFrame: From enrollment to the end of treatment at 3 months
measure: Gut microbiota analysis
timeFrame: From enrollment to the end of treatment at 3 months
measure: Short chain fatty acid contents
timeFrame: From enrollment to the end of treatment at 3 months
Secondary outcomes:
measure: Serum triglycerides
timeFrame: From enrollment to the end of treatment at 3 months
measure: Serum cholesterol
timeFrame: From enrollment to the end of treatment at 3 months
measure: Serum high density lipoprotein cholesterol
timeFrame: From enrollment to the end of treatment at 3 months
measure: Serum low density lipoprotein cholesterol
timeFrame: From enrollment to the end of treatment at 3 months
measure: Serum creatinine
timeFrame: From enrollment to the end of treatment at 3 months
measure: Serum uric acid
timeFrame: From enrollment to the end of treatment at 3 months
measure: Serum potassium
timeFrame: From enrollment to the end of treatment at 3 months
measure: Serum magnesium
timeFrame: From enrollment to the end of treatment at 3 months
measure: Urine pH
timeFrame: From enrollment to the end of treatment at 3 months
Other outcomes:
Locations:
city: Changshu City
country: China
facility: Changshu Hospital Affiliated to Soochow University
state: Jiangsu
Study officials:
affiliation: The Changshu Hospital Affiliated to Soochow University
name: Cheng Cao, MD
role: PRINCIPAL_INVESTIGATOR
References: