Uric Acid StonesNCT06118320
The Effective of Potassium Sodium Hydrogen Citrate in Treating Uric Acid Stones Using Gut Microbiota and Metabolomics.
An observational study of Uric Acid Stones, run by Cheng Cao at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Uric Acid Stones
- What is being tested?
- Potassium sodium hydrogen citrate
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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%).
Who may be able to join
- 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%).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changshu Hospital Affiliated to Soochow University
Changshu, Jiangsu, 215500
Ping Zhu, MD, +86 15150374982, zhuping5262@163.com
About this study
Official title: 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.
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.
Read the 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
- Being tested
- Potassium sodium hydrogen citrate
- Keywords
- gut microbiota, renal uric acid stone, 16S rRNA, short chain fatty acid, potassium sodium hydrogen citrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium sodium hydrogen citrateDrug
Also called PSHC
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Potassium sodium hydrogen citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 3 months
Secondary outcomes (9)
Serum triglycerides
The peripheral venous blood was collected pre- and post-intervention, and the serum triglyceride level (mmol/L) was measured by automatic biochemical analyzer.
Measured: From enrollment to the end of treatment at 3 months
Serum cholesterol
The peripheral venous blood was collected pre- and post-intervention, and the serum cholesterol level (mmol/L) was measured by automatic biochemical analyzer.
Measured: From enrollment to the end of treatment at 3 months
Serum high density lipoprotein cholesterol
The 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.
Measured: From enrollment to the end of treatment at 3 months
Serum low density lipoprotein cholesterol
The 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.
Measured: From enrollment to the end of treatment at 3 months
Serum creatinine
The 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.
Measured: From enrollment to the end of treatment at 3 months
Serum uric acid
The 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.
Measured: From enrollment to the end of treatment at 3 months
Serum potassium
The 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.
Measured: From enrollment to the end of treatment at 3 months
Serum magnesium
The 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.
Measured: From enrollment to the end of treatment at 3 months
Urine pH
The urine pH value was assessed by collecting mid-stream urine samples before and after the intervention by automatic biochemical analyzer.
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Mar 2022
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uric Acid StonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cheng Cao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cheng Cao, Changshu Affiliated Hospital of Soochow University
- Investigators
- Cheng Cao, MD, Principal investigator, The Changshu Hospital Affiliated to Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118320
- Sponsor's protocol ID
- ChangshuAHSU
- Status last verified
- Oct 2023
- First submitted
- 26 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06118320
- Acronym / sponsor ID
- ChangshuAHSU
- Conditions
- Uric Acid Stones
- Keywords
- gut microbiota, renal uric acid stone, 16S rRNA, short chain fatty acid, potassium sodium hydrogen citrate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cheng CaoUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug treatment group of uric acid stones（DT group） | – | Drug: Potassium sodium hydrogen citratePotassium 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. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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%).
Key inclusion criteria (1 listed)
- 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%).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Potassium sodium hydrogen citrateAlso: PSHCMedication: 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. | Drug | Drug treatment group of uric acid stones（DT group） |
Primary outcome
Maximum diameter of stone
Time frame: From enrollment to the end of treatment at 3 months
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.
Gut microbiota analysis
Time frame: From enrollment to the end of treatment at 3 months
The fecal samples were collected pre- and post-intervention for the analysis of gut microbiota.
Short chain fatty acid contents
Time frame: From enrollment to the end of treatment at 3 months
The collection of fecal samples was conducted both pre- and post-intervention in order to assess the levels of short-chain fatty acids.
9 secondary outcomes
Serum triglycerides
Time frame: From enrollment to the end of treatment at 3 months
Serum cholesterol
Time frame: From enrollment to the end of treatment at 3 months
Serum high density lipoprotein cholesterol
Time frame: From enrollment to the end of treatment at 3 months
Serum low density lipoprotein cholesterol
Time frame: From enrollment to the end of treatment at 3 months
Serum creatinine
Time frame: From enrollment to the end of treatment at 3 months
Serum uric acid
Time frame: From enrollment to the end of treatment at 3 months
Serum potassium
Time frame: From enrollment to the end of treatment at 3 months
Serum magnesium
Time frame: From enrollment to the end of treatment at 3 months
Urine pH
Time frame: From enrollment to the end of treatment at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheng Cao, MD principal investigator
The Changshu Hospital Affiliated to Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uric Acid Stones, run by Cheng Cao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ping Zhu, MD (+86 15150374982, zhuping5262@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum diameter of stone (time frame: From enrollment to the end of treatment at 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.