Study for the role of intestinal flora in latent and active infection of mycobacterium tuberculosis

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900026456

Enrollment

Unknown

Registered

2019-10-10

Start date

2019-11-01

Completion date

Unknown

Last updated

2019-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

tuberculosis

Interventions

Gold Standard:Gama-IFN release assay

Index test:HBHA-IGRA

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Occurrence time: June 2019-June 2020; 2. Include subjects in each group strictly according to the grouping criteria; 3. Aged 18-60 years old. Active tuberculosis (ATB) group: Meet the national diagnostic criteria for tuberculosis WS288-2017, included in the confirmed cases of tuberculosis; Latent tuberculosis infection(LTBI) group: from the high-risk population of tuberculosis infection (chest hospital medical staff, etc.) select IGRA test positive and exclude active ATB infection; Healthy control (HC) group: from the high-risk population of tuberculosis infection (chest). The negative IGRA test was selected among the medical staff of the Department hospital.

Exclusion criteria

Exclusion criteria: (1) History of autoimmune diseases; (2) Immunosuppression or deficiency; (3) digestive system tumors and inflammatory reactions; (4) Antibiotics used for more than a week in the past two months.

Design outcomes

Primary

Measure	Time frame
IFN-gama;SEN, SPE, ACC, AUC of ROC;	—

Countries

China

Contacts

Public ContactYueyun Ma

Department of Laboratory Medicine, Xijing Hospital, Air Force Medical University

cmbmayy@fmmu.edu.cn+86 13891921776

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026