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NCT06203249 Clinical Trial

Microecology and Immunity in Patients With Anti-MDA5 Antibody Positive Dermatomyositis and Interstitial Lung Disease

Microbiome Clinical Trial

Official title:
Microecology and Host Immunity in Patients With Anti-melanoma Differentiation Associated Gene 5 Antibody Positive Dermatomyositis and Interstitial Lung Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06203249
Other study ID # Microecology and Immunity 1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 20, 2024
Est. completion date November 25, 2026

Study information
Verified date January 2024
Source Chinese PLA General Hospital
Contact Zhimei Duan, doctor
Phone 13716376758
Email 549117002@qq.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study was to analyze the relationship between the microbial community, host immunity and the presence or absence of concurrent rapidly progressive interstitial lung disease patients with anti-MDA5 antibody positive dermatomyositis.

Description:

Methods: Bronchoalveolar lavage specimens of patients with anti-MDA5 antibody positive dermatomyositis and interstitial lung disease were collected and studied to analyze the relationship between the composition of patients' microecology and the occurrence and development of disease.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date November 25, 2026
Est. primary completion date December 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Patients who meet the diagnostic criteria of dermatomyositis and anti-MDA 5 antibody positive. - Anti-MDA5 antibody positive DM patients with RPILD meet the diagnostic criteria for RPILD. - Must have undergone bronchoalveolar lavage. - Age=18 years old. - Patients who signed informed consent forms Exclusion Criteria: - Patients who had other connective tissue diseases. - Patients with ILD or RPILD caused by infection, tumors, drugs, biochemistry and other factors. - Pregnant or lactating patients. - The patient also participated in any other clinical trial. - Disagreement for inclusion in this study

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China PLA Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The relationship between the microbial community and the presence or absence of interstitial lung disease The relationship between the microbial community and the presence or absence of interstitial lung disease 6 months
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