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

NCT07409870 | Not Yet Recruiting

• 1 other identifier: US-MOP202517401
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ureteral Stricture; Ureteral Obstruction; Microbiome; Metabolomics

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Study Arms (2)

Ureteral Stricture Group

Patients diagnosed with ureteral stricture through clinical symptoms, imaging (e.g., CT, IVP, or retrograde pyelography), or endoscopic evaluation. This cohort includes individuals with iatrogenic, inflammatory, or idiopathic strictures. Intervention of interest: Participants will undergo biological sample collection, including fecal samples for gut microbiome and metabolome analysis, mid-stream urine for urinary microbiome and metabolome analysis, and fasting blood samples for systemic serum metabolomic profiling. Clinical data such as renal function and stricture characteristics will also be recorded.

Healthy Control Group

Age- and sex-matched healthy volunteers with no history of ureteral stricture, urinary tract obstruction, or significant renal diseases. Candidates with recent (within 3 months) use of antibiotics or probiotics, or those with chronic gastrointestinal or metabolic disorders, are excluded. Intervention of interest: This cohort will provide identical biological samples (fecal, urine, and blood) following the same protocols as the patient group to establish a baseline for comparative multi-omics analysis.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

Department of Urology, The First Affiliated Hospital of Chongqing Medical University

Chongqing, 400016, China

Location

MeSH Terms

Conditions

Ureteral Obstruction

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Yang Pan, Doctor

CONTACT

86+13648331576; panyang361@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gang Chen

Study Record Dates

• First Submitted: February 7, 2026
• First Posted: February 13, 2026
• Study Start: February 1, 2026
• Primary Completion: June 30, 2026
• Study Completion: July 31, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

CN (1)