The goal of this observational study is to investigate the systemic pathogenesis and identify potential diagnostic biomarkers in patients with ureteral stricture and healthy volunteers. The main questions it aims to answer are:
What are the systemic differences in the gut microbiome, urine microbiome, and metabolomic profiles (fecal, urinary, and serum) between patients with ureteral stricture and healthy controls? What are the correlations between these microbial/metabolic alterations and clinical phenotypes, such as stricture severity, inflammatory levels, and renal function? Researchers will compare the biological panoramic profiles of patients with ureteral stricture to those of healthy controls to see if specific "microbiome-metabolite-disease" regulatory networks drive the development of the condition.
Participants will:
Provide stool samples for gut microbiome (16S/Metagenomics) and metabolomic analysis.
Provide urine samples for urine microbiome and metabolomic analysis. Provide blood (serum) samples for systemic metabolomic profiling. Undergo clinical assessments, including medical history collection, imaging (e.g., CT/IVP), and laboratory tests (e.g., renal function, inflammatory markers) to evaluate disease severity.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria (Ureteral Stricture Group):
Age between 18 and 75 years, regardless of gender. Diagnosis of ureteral stricture confirmed by clinical symptoms and imaging (e.g., CT, IVP, or retrograde pyelography) or ureteroscopy.
The patient is scheduled for or undergoing standard clinical evaluation/treatment for ureteral stricture.
Willingness to provide stool, urine, and blood samples. Informed consent signed by the participant or their legal representative.
Inclusion Criteria (Healthy Control Group):
Age- and sex-matched volunteers (18-75 years). No history of ureteral stricture, urinary tract obstruction, or significant renal disease.
Physical examination and laboratory tests (renal function, routine urine analysis) are within normal limits.
Exclusion Criteria (Applicable to Both Groups):
Use of antibiotics, probiotics, prebiotics, or antifungal medications within the 4 weeks prior to sample collection.
History of chronic gastrointestinal diseases (e.g., Inflammatory Bowel Disease (IBD), Irritable Bowel Syndrome (IBS), or chronic diarrhea).
Known malignant tumors of the urinary tract or other systemic malignancies. History of major abdominal or urinary tract surgery within the last 3 months (excluding the current planned procedure for patients).
Presence of severe systemic diseases, including uncontrolled diabetes, severe hepatic dysfunction, or end-stage heart failure.
Pregnancy or breastfeeding. Any other condition that, in the opinion of the investigator, may interfere with the microbiome or metabolomic analysis.
Primary outcome measure(s)
Differences in Gut and Urinary Microbiome Composition — Baseline (at the time of sample collection, within 1 week of enrollment) Comparison of microbial diversity and taxonomic composition between ureteral stricture patients and healthy controls. Metrics include Alpha-diversity (e.g., Shannon Index), Beta-diversity (e.g., PCoA based on Bray-Curtis distance), and relative abundance of specific microbial taxa from Phylum to Genus levels using 16S rRNA or metagenomic sequencing.
Differential Metabolomic Profiles in Fecal, Urinary, and Serum Samples — Baseline (at the time of sample collection, within 1 week of enrollment) Identification of significantly different metabolites between the two groups. Parameters include the concentration and relative intensity of metabolites identified via LC-MS/MS or GC-MS. Significant metabolites will be screened based on Variable Importance in Projection (VIP) \> 1.0 and p-value \< 0.05 from multivariate and univariate statistical analyses.
Trial sites (1)
Facility
City
Region
Status
Department of Urology, The First Affiliated Hospital of Chongqing Medical University
Chongqing
China
More First Affiliated Hospital of Chongqing Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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