Intestinal TuberculosisNCT07575061
A 15-year Cohort Study on Risk Factors of Mortality in Patients With Intestinal Tuberculosis
An observational study of Intestinal Tuberculosis, run by Beijing Chest Hospital, Capital Medical University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Tuberculosis
- What is being tested?
- Observational
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 Dec 2036
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Aged ≥18 years old (no upper age limit) at the time of intestinal tuberculosis diagnosis;
- Diagnosed with intestinal tuberculosis in accordance with clinical diagnostic criteria (combined with clinical manifestations, laboratory examinations, imaging findings, and/or pathological results);
- For the Retrospective Intestinal Tuberculosis Cohort: diagnosed between January 2011 and December 2025, with complete medical records and follow-up data (including mortality status);
- For the Prospective Intestinal Tuberculosis Cohort: newly diagnosed, able to cooperate with regular follow-up, and sign the informed consent form (if applicable);
- No severe cognitive impairment or mental illness that affects the collection of clinical data and follow-up.
Who cannot join
- Patients with incomplete diagnosis of intestinal tuberculosis (no clear clinical, laboratory, imaging or pathological evidence to confirm the diagnosis);
- Patients with concurrent severe extrapulmonary tuberculosis (such as tuberculous meningitis, miliary tuberculosis) that may independently affect mortality outcomes;
- 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);
- 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;
- 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;
- Patients with cognitive impairment, mental illness or other conditions that cannot provide effective clinical information or cooperate with the study.
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, 1 recruiting
- Recruiting
Beijing Chest Hospital
Beijing, Beijing Municipality, 101149
Wenjuan N Nie, MD, +86010-89509321
About this study
Official title: 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.
- Conditions
- Intestinal Tuberculosis
- Being tested
- Observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 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. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality in patients with intestinal tuberculosis.
Death of the study subject due to any cause during the study period
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Jan 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal TuberculosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chest Hospital, Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuelian Li, Beijing Chest Hospital, Capital Medical University
- Investigators
- Wenjuan Nie, MD, Study chair, Beijing Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575061
- Sponsor's protocol ID
- LW-2026-013
- Status last verified
- May 2026
- First submitted
- 3 May 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The shared IPD includes de-identified clinical data of research subjects.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 15-Year Cohort Study to Analyze Risk Factors for Mortality in Patients With Intestinal Tuberculosis
- ClinicalTrials.gov ID
- NCT07575061
- Acronym / sponsor ID
- LW-2026-013
- Conditions
- Intestinal Tuberculosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Beijing Chest Hospital, Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2036 (estimated)
- First posted
- 8 May 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Intestinal Tuberculosis Cohort | – | Other: ObservationalThis 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. |
| Prospective Intestinal Tuberculosis Cohort | – | Other: ObservationalThis 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Aged ≥18 years old (no upper age limit) at the time of intestinal tuberculosis diagnosis;
- Diagnosed with intestinal tuberculosis in accordance with clinical diagnostic criteria (combined with clinical manifestations, laboratory examinations, imaging findings, and/or pathological results);
- For the Retrospective Intestinal Tuberculosis Cohort: diagnosed between January 2011 and December 2025, with complete medical records and follow-up data (including mortality status);
- For the Prospective Intestinal Tuberculosis Cohort: newly diagnosed, able to cooperate with regular follow-up, and sign the informed consent form (if applicable);
- No severe cognitive impairment or mental illness that affects the collection of clinical data and follow-up.
Key exclusion criteria (6 listed)
- Patients with incomplete diagnosis of intestinal tuberculosis (no clear clinical, laboratory, imaging or pathological evidence to confirm the diagnosis);
- Patients with concurrent severe extrapulmonary tuberculosis (such as tuberculous meningitis, miliary tuberculosis) that may independently affect mortality outcomes;
- 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);
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalObservational | Other | Prospective Intestinal Tuberculosis Cohort, Retrospective Intestinal Tuberculosis Cohort |
Primary outcome
All-cause mortality in patients with intestinal tuberculosis.
Time frame: 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
Death of the study subject due to any cause during the study period
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 8 May 2026.
- Individual participant dataSharing planned: Yes. The shared IPD includes de-identified clinical data of research subjects.
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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.
Wenjuan Nie, MD study chair
Beijing Chest Hospital
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 Intestinal Tuberculosis, run by Beijing Chest Hospital, Capital 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 6 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: looking for participants now, as of the sponsor's last update on 8 May 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 Xuelian X Li, MD (+86 010-89509321, lilyxuelian@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality in patients with intestinal tuberculosis. (time frame: 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). 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 8 May 2026.