Clinical trial
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.
Name
ChangshuAHSU
Description
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.
Trial arms
Trial start
2022-03-01
Estimated PCD
2024-03-30
Trial end
2024-06-30
Status
Recruiting
Treatment
Potassium sodium hydrogen citrate
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.
Arms:
Drug treatment group of uric acid stones（DT group）
Other names:
PSHC
Size
30
Primary endpoint
Maximum diameter of stone
From enrollment to the end of treatment at 3 months
Gut microbiota analysis
From enrollment to the end of treatment at 3 months
Short chain fatty acid contents
From enrollment to the end of treatment at 3 months
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2023-11-07
1 organization
1 product
1 indication
Organization
Cheng CaoIndication
Uric Acid Stones