Skip to content

The Effective of Potassium Sodium Hydrogen Citrate in Treating Uric Acid Stones Using Gut Microbiota and Metabolomics.

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.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06118320
Enrollment
30
Registered
2023-11-07
Start date
2022-03-01
Completion date
2024-06-30
Last updated
2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uric Acid Stones

Keywords

gut microbiota, renal uric acid stone, 16S rRNA, short chain fatty acid, potassium sodium hydrogen citrate

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.

Interventions

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.

Sponsors

Cheng Cao
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Gut microbiota analysisFrom enrollment to the end of treatment at 3 monthsThe fecal samples were collected pre- and post-intervention for the analysis of gut microbiota.
Maximum diameter of stoneFrom enrollment to the end of treatment at 3 monthsThe patients underwent pre- and post-drug intervention abdominal CT examinations, enabling determination of the stone's maximum diameter(mm) through analysis of CT images.
Short chain fatty acid contentsFrom enrollment to the end of treatment at 3 monthsThe collection of fecal samples was conducted both pre- and post-intervention in order to assess the levels of short-chain fatty acids.

Secondary

MeasureTime frameDescription
Serum low density lipoprotein cholesterolFrom enrollment to the end of treatment at 3 monthsThe 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.
Serum creatinineFrom enrollment to the end of treatment at 3 monthsThe 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.
Serum uric acidFrom enrollment to the end of treatment at 3 monthsThe 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.
Serum triglyceridesFrom enrollment to the end of treatment at 3 monthsThe peripheral venous blood was collected pre- and post-intervention, and the serum triglyceride level (mmol/L) was measured by automatic biochemical analyzer.
Serum magnesiumFrom enrollment to the end of treatment at 3 monthsThe 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.
Urine pHFrom enrollment to the end of treatment at 3 monthsThe urine pH value was assessed by collecting mid-stream urine samples before and after the intervention by automatic biochemical analyzer.
Serum potassiumFrom enrollment to the end of treatment at 3 monthsThe 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.
Serum cholesterolFrom enrollment to the end of treatment at 3 monthsThe peripheral venous blood was collected pre- and post-intervention, and the serum cholesterol level (mmol/L) was measured by automatic biochemical analyzer.
Serum high density lipoprotein cholesterolFrom enrollment to the end of treatment at 3 monthsThe 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.

Countries

China

Contacts

Primary ContactPing Zhu, MD
zhuping5262@163.com+86 15150374982

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026