Ureteral StrictureUS-MOPNCT07409870
An Integrated Multi-omics Study on the Molecular Mechanisms of Ureteral Stricture
An observational study of Ureteral Stricture and Ureteral Obstruction, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ureteral Stricture, Ureteral Obstruction, Microbiome
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 31 Jul 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Urology, The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016
Yang Pan, Doctor, 86+13648331576, panyang361@163.com
About this study
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.
Read more
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.
Read the detailed description
Background and Scientific Rationale Ureteral stricture is a major urological challenge that leads to urinary tract obstruction and progressive renal impairment. While its etiology is diverse-ranging from iatrogenic injury to congenital anomalies-the underlying molecular mechanisms, particularly in inflammatory and idiopathic cases, remain poorly understood. Current surgical interventions carry a risk of recurrence, underscoring the urgent need to identify systemic biomarkers and novel therapeutic targets.
The Gut-Kidney Axis and Urinary Microbiome Recent advances have highlighted the "gut-kidney axis," where the gut microbiota and its metabolites modulate distant organ pathology through immune regulation and metabolic signaling. Furthermore, the discovery of a unique urinary microbiome has challenged the traditional view of urinary sterility, suggesting that local dysbiosis may contribute to urological diseases. Metabolites, serving as the functional intermediaries between the microbiome and the host phenotype, provide a critical bridge to understanding these complex interactions.
Integrated Multi-omics Strategy
This study adopts an innovative integrated multi-omics approach to characterize the biological landscape of ureteral stricture across three compartments: the intestine, the urinary tract, and the systemic circulation. By combining high-throughput sequencing of gut and urine microbiomes with mass spectrometry-based metabolomic profiling (fecal, urinary, and serum), we aim to:
Map Systemic Dysbiosis: Identify specific microbial taxa and metabolic signatures that distinguish patients with ureteral stricture from healthy individuals.
Elucidate Regulatory Networks: Construct "microbiome-metabolite-disease" networks to explore how microbial alterations correlate with clinical phenotypes, such as fibrosis markers, inflammatory levels, and renal function indicators.
Identify Functional Pathways: Utilize functional enrichment analysis to pinpoint metabolic pathways (e.g., those related to inflammation or tissue fibrosis) that are modulated by the microbiota.
Clinical Significance The ultimate goal of this research is to provide a systemic biological perspective on the pathogenesis of ureteral stricture. By integrating cross-platform data, we expect to identify high-sensitivity non-invasive biomarkers for early diagnosis and provide a theoretical foundation for future microecology-targeted interventions.
- Conditions
- Ureteral Stricture, Ureteral Obstruction, Microbiome, Metabolomics
- Medical subject headings
- Ureteral Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (at the time of sample collection, within 1 week of enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral StrictureStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Chen, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409870
- Sponsor's protocol ID
- US-MOP202517401
- Acronym
- US-MOP
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision to share individual participant data (IPD) is currently under evaluation. The investigators will finalize the data sharing plan after reviewing the institutional data management policies and ensuring that all sharing protocols strictly adhere to participant privacy and ethical guidelines. A final determination will be made at the time of publication.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Multi-omics Study on the Molecular Mechanisms of Ureteral Stricture
- ClinicalTrials.gov ID
- NCT07409870
- Acronym / sponsor ID
- US-MOP / US-MOP202517401
- Conditions
- Ureteral Stricture, Ureteral Obstruction, Microbiome, Metabolomics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 13 Feb 2026 (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 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.
Detailed description
Background and Scientific Rationale Ureteral stricture is a major urological challenge that leads to urinary tract obstruction and progressive renal impairment. While its etiology is diverse-ranging from iatrogenic injury to congenital anomalies-the underlying molecular mechanisms, particularly in inflammatory and idiopathic cases, remain poorly understood. Current surgical interventions carry a risk of recurrence, underscoring the urgent need to identify systemic biomarkers and novel therapeutic targets.
The Gut-Kidney Axis and Urinary Microbiome Recent advances have highlighted the "gut-kidney axis," where the gut microbiota and its metabolites modulate distant organ pathology through immune regulation and metabolic signaling. Furthermore, the discovery of a unique urinary microbiome has challenged the traditional view of urinary sterility, suggesting that local dysbiosis may contribute to urological diseases. Metabolites, serving as the functional intermediaries between the microbiome and the host phenotype, provide a critical bridge to understanding these complex interactions.
Integrated Multi-omics Strategy
This study adopts an innovative integrated multi-omics approach to characterize the biological landscape of ureteral stricture across three compartments: the intestine, the urinary tract, and the systemic circulation. By combining high-throughput sequencing of gut and urine microbiomes with mass spectrometry-based metabolomic profiling (fecal, urinary, and serum), we aim to:
Map Systemic Dysbiosis: Identify specific microbial taxa and metabolic signatures that distinguish patients with ureteral stricture from healthy individuals.
Elucidate Regulatory Networks: Construct "microbiome-metabolite-disease" networks to explore how microbial alterations correlate with clinical phenotypes, such as fibrosis markers, inflammatory levels, and renal function indicators.
Identify Functional Pathways: Utilize functional enrichment analysis to pinpoint metabolic pathways (e.g., those related to inflammation or tissue fibrosis) that are modulated by the microbiota.
Clinical Significance The ultimate goal of this research is to provide a systemic biological perspective on the pathogenesis of ureteral stricture. By integrating cross-platform data, we expect to identify high-sensitivity non-invasive biomarkers for early diagnosis and provide a theoretical foundation for future microecology-targeted interventions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences in Gut and Urinary Microbiome Composition
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: Undecided. The decision to share individual participant data (IPD) is currently under evaluation. The investigators will finalize the data sharing plan after reviewing the institutional data management policies and ensuring that all sharing protocols strictly adhere to participant privacy and ethical guidelines. A final determination will be made at the time of publication.
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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.
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 Ureteral Stricture and Ureteral Obstruction, run by First Affiliated Hospital of Chongqing Medical University 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 13 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Pan, Doctor (86+13648331576, panyang361@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Gut and Urinary Microbiome Composition (time frame: Baseline (at the time of sample collection, within 1 week of enrollment)). The study lists 2 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 13 Feb 2026.