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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Short chain fatty acid contents
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%).
排除标准
- •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.
研究组 & 干预措施
Drug treatment group of uric acid stones（DT group）
Potassium sodium hydrogen citrate granules (MADAUS GMBH, Germany, 2.5g/packet) were administered to patients with residual stones (>5 mm in diameter) after surgery or difficult-to-remove stones in the infrarenal calyces for a three-month intervention period. The medication was taken as follows: one packet after breakfast, one packet after lunch, and two packets after dinner. Participants were instructed to abstain from alcohol consumption, smoking, and the use of any probiotics or medications that lower uric acid levels during the therapeutic period.They were also instructed to monitor preprandial urine pH levels to maintain an effective range of 6.2-6.8.
干预措施: Potassium sodium hydrogen citrate (Drug)
结局指标
主要结局
Short chain fatty acid contents
时间窗: From enrollment to the end of treatment at 3 months
The collection of fecal samples was conducted both pre- and post-intervention in order to assess the levels of short-chain fatty acids.
Maximum diameter of stone
时间窗: From enrollment to the end of treatment at 3 months
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.
Gut microbiota analysis
时间窗: From enrollment to the end of treatment at 3 months
The fecal samples were collected pre- and post-intervention for the analysis of gut microbiota.
次要结局
- Serum high density lipoprotein cholesterol(From enrollment to the end of treatment at 3 months)
- Serum low density lipoprotein cholesterol(From enrollment to the end of treatment at 3 months)
- Serum creatinine(From enrollment to the end of treatment at 3 months)
- Serum potassium(From enrollment to the end of treatment at 3 months)
- Serum triglycerides(From enrollment to the end of treatment at 3 months)
- Serum cholesterol(From enrollment to the end of treatment at 3 months)
- Serum magnesium(From enrollment to the end of treatment at 3 months)
- Urine pH(From enrollment to the end of treatment at 3 months)
- Serum uric acid(From enrollment to the end of treatment at 3 months)
研究者
Cheng Cao
MD
Changshu Affiliated Hospital of Soochow University