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

January 10, 2024 updated by: wang kaifei, Chinese PLA General Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • PLA
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Anti-MDA5 antibody positive dermatomyositis patients with or without interstitial lung disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The relationship between the microbial community and the presence or absence of interstitial lung disease
Time Frame: 6 months
The relationship between the microbial community and the presence or absence of interstitial lung disease
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 20, 2024

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

November 25, 2026

Study Registration Dates

First Submitted

December 28, 2023

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Microecology and Immunity 1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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