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

NCT ID: NCT06118320

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2024-06-30

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.

Conditions

Uric Acid Stones

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Potassium sodium hydrogen citrate

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

PSHC

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cheng Cao

OTHER

Sponsor Role: lead

Responsible Party

Cheng Cao

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Cheng Cao, MD

Role: PRINCIPAL_INVESTIGATOR

The Changshu Hospital Affiliated to Soochow University

Locations

Changshu Hospital Affiliated to Soochow University

Changshu, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ping Zhu, MD

Role: CONTACT

zhuping5262@163.com

+86 15150374982

Facility Contacts

Ping Zhu, MD

Role: primary

zhuping5262@163.com

+86 15150374982

Other Identifiers

ChangshuAHSU

Identifier Type: -

Identifier Source: org_study_id