A 15-year Cohort Study on Risk Factors of Mortality in Patients With Intestinal Tuberculosis

A 15-Year Cohort Study to Analyze Risk Factors for Mortality in Patients With Intestinal Tuberculosis

This study adopts a combined design of retrospective cohort study followed by prospective observational study, which is conducted at Beijing Chest Hospital. The study first collects and analyzes the data of intestinal tuberculosis patients diagnosed and followed up in the hospital from 2011-1 to 2025-12 (a 15-year retrospective period) as the retrospective cohort, aiming to initially identify the risk factors associated with mortality in patients with intestinal tuberculosis. On the basis of the retrospective analysis results, the study will further carry out a prospective observational study, continuously enroll new intestinal tuberculosis patients, follow up their clinical status, treatment response and mortality outcomes for a certain period, and verify and supplement the risk factors identified in the retrospective stage. Clinical data, including demographic characteristics, clinical manifestations, laboratory test results, treatment regimens, and follow-up outcomes (mortality status), will be collected and sorted out in both stages. Univariate and multivariate statistical analyses will be used to screen and verify potential risk factors (such as age, disease severity, comorbidities, and treatment compliance) that affect the mortality of patients with intestinal tuberculosis. The results of this study are expected to provide scientific evidence for optimizing the clinical management, risk assessment, and prognostic improvement of patients with intestinal tuberculosis, and further guide the formulation of targeted prevention and treatment strategies.

Study Overview

• Status: Recruiting
• Conditions: Intestinal Tuberculosis
• Intervention / Treatment: Other: Observational

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Xuelian X Li, MD; Phone Number: +86 010-89509321; Email: lilyxuelian@126.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 101149
      • Recruiting
      • Beijing Chest Hospital
      • Contact: Wenjuan N Nie, MD; Phone Number: +86010-89509321

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The study population consists of patients diagnosed with intestinal tuberculosis, covering both the retrospective and prospective research stages. The Retrospective Intestinal Tuberculosis Cohort includes patients diagnosed with intestinal tuberculosis between January 2011 and December 2025, with complete medical records and follow-up data (including mortality status). The Prospective Intestinal Tuberculosis Cohort includes newly diagnosed intestinal tuberculosis patients who can cooperate with follow-up and provide complete clinical information. The study population is mainly used to analyze the risk factors related to mortality in intestinal tuberculosis patients, so as to provide a scientific basis for optimizing clinical management and improving the prognosis of patients.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Retrospective Intestinal Tuberculosis Cohort; This cohort includes intestinal tuberculosis patients diagnosed and followed up in Beijing Chest Hospital from 2011-01 to 2025-12 (15-year retrospective period). The research data are collected by reviewing historical medical records, mainly used for initial screening of mortality-related risk factors.	Other: Observational; Observational
Prospective Intestinal Tuberculosis Cohort; This cohort includes newly diagnosed intestinal tuberculosis patients enrolled continuously after the retrospective stage. The research data are collected through dynamic follow-up of the subjects, mainly used for verifying and supplementing the mortality-related risk factors identified in the retrospective cohort.	Other: Observational; Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality in patients with intestinal tuberculosis.	Death of the study subject due to any cause during the study period	For the Retrospective Intestinal Tuberculosis Cohort, the time frame is 15 years, from January 2011 to December 2025; for the Prospective Intestinal Tuberculosis Cohort, the time frame is 3 years from the date of the first patient enrollment

Collaborators and Investigators

• Sponsor: Beijing Chest Hospital, Capital Medical University
• Investigators: Study Chair: Wenjuan Nie, MD, Beijing Chest Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2036

Study Registration Dates

• First Submitted: May 3, 2026
• First Submitted That Met QC Criteria: May 3, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 3, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services Administration; Quality of Health Care; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Watchful Waiting
• Other Study ID Numbers: LW-2026-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The shared IPD includes de-identified clinical data of research subjects.
• IPD Sharing Time Frame: IPD will be made available for sharing after the completion of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No