Investigating potassium sodium hydrogen citrate for treating uric acid stones
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.
Changshu Affiliated Hospital of Soochow University · NCT06118320
This study is testing if potassium sodium hydrogen citrate can help people with uric acid stones by looking at how it affects their gut bacteria and other substances in their body over three months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | Changshu Affiliated Hospital of Soochow University (other) |
| Locations | 1 site (Changshu City, Jiangsu) |
| Trial ID | NCT06118320 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore how potassium sodium hydrogen citrate affects gut microbiota and metabolites in patients with uric acid stones. Participants will undergo a 3-month treatment while providing blood, urine, and stool samples before and after the intervention. The study will analyze the relationship between gut bacteria, short-chain fatty acids, and biochemical markers to identify potential metabolic mechanisms for treatment. No additional interventions will be made beyond the administration of the drug.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with uric acid stones confirmed through imaging techniques.
Not a fit: Patients with malignancies, chronic liver insufficiency, or a history of certain metabolic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into a novel treatment approach for patients suffering from uric acid stones.
How similar studies have performed: While the approach of analyzing gut microbiota in relation to uric acid stones is relatively novel, similar studies have shown promising results in other conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Changshu City, Jiangsu
- Changshu Hospital Affiliated to Soochow University — Changshu City, Jiangsu, China (RECRUITING)
Study contacts
- Principal investigator: Cheng Cao, MD — The Changshu Hospital Affiliated to Soochow University
- Study coordinator: Ping Zhu, MD
- Email: zhuping5262@163.com
- Phone: +86 15150374982
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Uric Acid Stones, gut microbiota, renal uric acid stone, 16S rRNA, short chain fatty acid, potassium sodium hydrogen citrate