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

Last updated: October 31, 2023
Sponsor: Cheng Cao
Overall Status: Active - Recruiting

Phase

N/A

Condition

Kidney Stones

Treatment

Potassium sodium hydrogen citrate

Clinical Study ID

NCT06118320
ChangshuAHSU
  • Ages 30-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 throughureteroscopic lithotripsy (URSL), percutaneous nephrolithotomy (PCNL), or extracorporealshock wave lithotripsy (ESWL). Stones were analyzed using an automated infraredspectroscopy system, LIIR-20 (Lanmode Scientific Instrument Co., Ltd., Tianjin, China), andthe main components were determined based on the most abundant substances listed in thereport, which were classified as pure or mixed uric acid stones (anhydrous uric acidcontent >50%).

Exclusion

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

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Potassium sodium hydrogen citrate
Phase:
Study Start date:
March 01, 2022
Estimated Completion Date:
June 30, 2024

Study 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.

Connect with a study center

  • Changshu Hospital Affiliated to Soochow University

    Changshu City, Jiangsu 215500
    China

    Active - Recruiting

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