15-year look at what raises the risk of death in people with intestinal tuberculosis
A 15-Year Cohort Study to Analyze Risk Factors for Mortality in Patients With Intestinal Tuberculosis
This project will see which clinical, laboratory, and treatment factors are linked to a higher risk of death in adults with intestinal tuberculosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Beijing Chest Hospital, Capital Medical University Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07575061 on ClinicalTrials.gov |
What this trial studies
This is a combined retrospective and prospective cohort run at Beijing Chest Hospital that first analyzes patient records from January 2011 to December 2025 and then enrolls newly diagnosed patients for prospective follow-up. The team will collect demographic information, clinical symptoms, laboratory and imaging results, pathology when available, treatment regimens, and mortality outcomes. Findings from the retrospective phase will guide which risk factors are tested and validated in the prospective cohort. The goal is to identify and confirm factors that predict mortality in adults with confirmed intestinal tuberculosis.
Who should consider this trial
Good fit: Adults (18 or older) with a confirmed diagnosis of intestinal tuberculosis treated at Beijing Chest Hospital, including those with complete past records for the retrospective arm and newly diagnosed patients willing to consent and attend follow-up for the prospective arm.
Not a fit: People under 18, those without a clear confirmed diagnosis, patients with incomplete medical records, or those unable to attend follow-up visits are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, clinicians could better identify high-risk patients and adjust monitoring or treatment to help reduce deaths from intestinal tuberculosis.
How similar studies have performed: Prior tuberculosis cohort studies have identified mortality risk factors, but long-term, intestinal tuberculosis-specific 15-year cohort data are limited, so this work builds on but extends earlier findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged ≥18 years old (no upper age limit) at the time of intestinal tuberculosis diagnosis; 2. Diagnosed with intestinal tuberculosis in accordance with clinical diagnostic criteria (combined with clinical manifestations, laboratory examinations, imaging findings, and/or pathological results); 3. For the Retrospective Intestinal Tuberculosis Cohort: diagnosed between January 2011 and December 2025, with complete medical records and follow-up data (including mortality status); 4. For the Prospective Intestinal Tuberculosis Cohort: newly diagnosed, able to cooperate with regular follow-up, and sign the informed consent form (if applicable); 5. No severe cognitive impairment or mental illness that affects the collection of clinical data and follow-up. Exclusion Criteria: 1. Patients with incomplete diagnosis of intestinal tuberculosis (no clear clinical, laboratory, imaging or pathological evidence to confirm the diagnosis); 2. Patients with concurrent severe extrapulmonary tuberculosis (such as tuberculous meningitis, miliary tuberculosis) that may independently affect mortality outcomes; 3. For the Retrospective Intestinal Tuberculosis Cohort: patients with incomplete medical records or missing key follow-up data (especially mortality status and related risk factor information); 4. For the Prospective Intestinal Tuberculosis Cohort: patients who refuse to sign the informed consent form (if applicable), cannot cooperate with regular follow-up, or are lost to follow-up during the study period; 5. Patients with severe comorbidities that may lead to rapid death (such as advanced malignant tumors, severe heart failure, end-stage liver/kidney disease) within the study period, which may interfere with the analysis of mortality risk factors related to intestinal tuberculosis; 6. Patients with cognitive impairment, mental illness or other conditions that cannot provide effective clinical information or cooperate with the study.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Chest Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xuelian X Li, MD
- Email: lilyxuelian@126.com
- Phone: +86 010-89509321
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.