MicrobiomeNCT06203249
Microecology and Immunity in Patients With Anti-MDA5 Antibody Positive Dermatomyositis and Interstitial Lung Disease
An observational study of Microbiome and Immune Function, run by Chinese PLA General Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Microbiome, Immune Function, Anti-MDA5 Antibody Positive Dermatomyositis
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2024to 25 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Anti-MDA5 antibody positive dermatomyositis patients with or without interstitial lung disease
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
PLA
Beijing, Beijing Municipality, 100853
Zhimei Duan, doctor, 13716376758, 549117002@qq.com
About this study
Official title: 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.
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start20 Jan 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion25 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrobiomeStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wang kaifei, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203249
- Sponsor's protocol ID
- Microecology and Immunity 1
- Status last verified
- Jan 2024
- First submitted
- 28 Dec 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microecology and Host Immunity in Patients With Anti-melanoma Differentiation Associated Gene 5 Antibody Positive Dermatomyositis and Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT06203249
- Acronym / sponsor ID
- Microecology and Immunity 1
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 20 Jan 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 25 Nov 2026 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Anti-MDA5 antibody positive dermatomyositis patients with or without interstitial lung disease
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microbiome and Immune Function, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhimei Duan, doctor (13716376758, 549117002@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relationship between the microbial community and the presence or absence of interstitial lung disease (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.