Analyzing the relationship between gut bacteria and immune response in patients with a specific type of dermatomyositis and lung disease
Microecology and Host Immunity in Patients With Anti-melanoma Differentiation Associated Gene 5 Antibody Positive Dermatomyositis and Interstitial Lung Disease
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 type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06203249 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While the specific approach of this study may be novel, similar studies investigating the microbiome's role in autoimmune diseases have shown promising results.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- Pla — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Zhimei Duan, doctor
- Email: 549117002@qq.com
- Phone: 13716376758
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.