Clinical trial Recruiting at 1 site Observational Ages 18 to 100

Analyzing the relationship between gut bacteria and immune response in patients with a specific type of dermatomyositis and lung disease

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

Run by Chinese PLA General Hospital · NCT06203249 · Data updated 2026-11-12

This study is trying to see how the bacteria in the gut affect the immune system in patients with a specific type of skin and lung disease.

Quick facts

Study typeObservational
Ages18 Years to 100 Years
SexAll
Enrollment50 (estimated)
SponsorChinese PLA General Hospital
Academic / other
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedJanuary 20, 2024
Main results expectedDecember 30, 2025
Study endsNovember 25, 2026
Registry record updatedJanuary 12, 2024
Trial IDNCT06203249 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18 and older who have been diagnosed with anti-MDA5 antibody positive dermatomyositis and rapidly progressive interstitial lung disease.

Probably not a fit

Patients with other connective tissue diseases or those whose interstitial lung disease is caused by infections, tumors, or other factors may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate how the microbial community in the body interacts with the immune system in patients who have anti-MDA5 antibody positive dermatomyositis and concurrent rapidly progressive interstitial lung disease. Researchers will collect bronchoalveolar lavage specimens from these patients to analyze the composition of their microecology and its potential impact on disease progression. The study focuses on understanding the connection between microbiome diversity and immune function in this specific patient population.

Why it matters

Potential benefit: If successful, this study could lead to new insights into the treatment and management of dermatomyositis and interstitial lung disease by targeting microbiome-related factors.

How similar studies have gone: While the specific approach of this study may be novel, similar studies investigating the microbiome's role in autoimmune diseases have shown promising results.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Pla
    Beijing, Beijing Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.