An Integrated Multi-omics Study on the Molecular Mechanisms of Ureteral Stricture

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFirst Affiliated Hospital of Chongqing Medical University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

The study population consists of adult patients diagnosed with ureteral stricture who are seeking medical consultation or surgical treatment at the Department of Urology in a tertiary medical center The First Affiliated Hospital of Chongqing Medical University. These patients represent a diverse range of etiologies, including iatrogenic, inflammatory, and idiopathic narrowing. Simultaneously, a cohort of healthy volunteers will be recruited from the hospital's physical examination center or the local community to serve as the control group. These volunteers are age- and sex-matched to the patient group and share a similar geographic and dietary background to minimize environmental confounding factors in microbiome and metabolomic analysis.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 2 trial groups
Group A: Ureteral Stricture Group
Group B: Healthy Control Group

Trial outcomes

Primary outcomes

1

Differences in Gut and Urinary Microbiome Composition

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.

Time frame
Baseline (at the time of sample collection, within 1 week of enrollment)
2

Differential Metabolomic Profiles in Fecal, Urinary, and Serum Samples

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.

Time frame
Baseline (at the time of sample collection, within 1 week of enrollment)

Secondary outcomes

Other outcomes

Sponsors and contacts

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