ClinicalTrials.gov record NCT06203249

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.The registry record was last updated on Jan 12, 2024, about 2 years ago, so the status shown may be out of date. The study team or the registry can confirm.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old to 100 years old
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This observational cohort study collects bronchoalveolar lavage (lung fluid) from adults with anti‑MDA5 antibody–positive dermatomyositis, with or without interstitial lung disease. Investigators analyze the lung microbial community and host immune features to examine links with the presence or development of interstitial lung disease, including rapidly progressive ILD. Participation involves providing bronchoalveolar lavage samples for laboratory study.

What it is studying. Whether the composition of lung microbes and features of the host immune response are associated with the presence or development of interstitial lung disease (including rapidly progressive ILD) in people with anti‑MDA5 antibody–positive dermatomyositis.

What the researchers hope to learn. To describe and analyze the relationship between lung microbiome composition, host immunity, and the presence or absence of interstitial lung disease in people with anti‑MDA5 antibody–positive dermatomyositis.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This study analyses bronchoalveolar lavage (BAL) samples — fluid washed into and collected back out of the lungs. The registry requires that you have already had a BAL to take part; it does not say the study performs one. The samples are studied to examine the microbes and immune characteristics in the lungs. Participation requires giving informed consent. The record does not list other tests, visits, or follow‑up procedures.

How the study is structured. Observational cohort study. Bronchoalveolar lavage specimens are collected and analyzed to study lung microbial composition and host immunity in participants with and without interstitial lung disease. No treatments are assigned.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on dermatomyositis

Clinical trials59 trials listed for dermatomyositisEvery trial the registry lists for dermatomyositis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in dermatomyositis researchLatest monthly update: September 2026. Includes: Upadacitinib case reports. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jan 20, 2024 (estimated)
Primary completion
Dec 30, 2025 (estimated)
Study completion
Nov 25, 2026 (estimated)
Target enrollment
50 participants (estimated)
Last updated on registry
Jan 12, 2024
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Chinese PLA General Hospital
Principal investigator
wang kaifei, Chinese PLA General Hospital
Chinese PLA General Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
clinical trial
A study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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