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

NCT06118320 | Unknown

• 1 other identifier: ChangshuAHSU
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Uric Acid Stones

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Maximum diameter of stone

  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.

  From enrollment to the end of treatment at 3 months

• Gut microbiota analysis

  The fecal samples were collected pre- and post-intervention for the analysis of gut microbiota.

  From enrollment to the end of treatment at 3 months

• Short chain fatty acid contents

  The collection of fecal samples was conducted both pre- and post-intervention in order to assess the levels of short-chain fatty acids.

  From enrollment to the end of treatment at 3 months

Secondary Outcomes (9)

• 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 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

Study Arms (1)

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.

Drug: Potassium sodium hydrogen citrate

Interventions

Potassium sodium hydrogen citrate 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.

Also known as: PSHC

Drug treatment group of uric acid stones（DT group）

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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%).

You may qualify if:

• 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%).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cheng Cao: lead

Study Sites (1)

Changshu Hospital Affiliated to Soochow University

Changshu, Jiangsu, 215500, China

RECRUITING

Study Officials

• Cheng Cao, MD

  The Changshu Hospital Affiliated to Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping Zhu, MD

CONTACT

+86 15150374982; zhuping5262@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 7, 2023
• Study Start: March 1, 2022
• Primary Completion: March 30, 2024
• Study Completion: June 30, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)