Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT06118320
Status:
UNKNOWN
Last Update Posted:
2023-11-07
First Post:
2023-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effective of Potassium Sodium Hydrogen Citrate in Treating Uric Acid Stones Using Gut Microbiota and Metabolomics.
Sponsor:
Cheng Cao
Organization:
Study Overview
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.
Status:
UNKNOWN
Status Verified Date:
2023-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: