- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02520323
The Lung Microbiome in Sarcoidosis
June 2, 2017 updated by: Eric S. White, MD, University of Michigan
The objective of this study is to determine the presence of bacterial species, and the immunologic and molecular mechanisms of granuloma formation that might be involved in the pathogenesis of sarcoidosis.
The investigators will collect peripheral blood and bronchoalveolar lavage fluid samples to isolate bacterial DNA and blood monocytes and lymphocytes.
Specimens will be obtained from patients with sarcoidosis, with non-sarcoid lung disease, and healthy volunteers to directly compare the bacterial species present and the characteristics of cells thought to be involved in granuloma formation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
21
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Medical Center
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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
30 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Potential subjects will be patients with sarcoidosis (involving any organ system), with non-sarcoid interstitial lung disease, and healthy controls.
Description
Inclusion Criteria:
- Clinical diagnosis of sarcoidosis (30 subjects) or
- Clinical diagnosis of non-sarcoid interstitial lung disease (10 subjects) or
- Age-matched controls (30 subjects)
- Ability to provide informed consent
Exclusion Criteria:
- Any disease condition (such as anemia, unstable cardiac disease, etc.) that in the opinion of the subject's primary physician would put the patient at risk of harm from having 60 cc of blood drawn or for undergoing bronchoscopy for this study.
- Patients who are undergoing bronchoscopy for presumed infection.
- Pregnant women, women who may be pregnant, and women who are breastfeeding.
- Patients who have undergone lung transplantation.
- Persons who are unable or unwilling to undergo bronchoscopy, including those unable to be accompanied by a designated driver to the procedure.
- Persons who have taken antibiotics in the 90 days prior to consent.
- Known HIV, HCV, alcohol, or other substance abuse history.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Blood only
20 sarcoidosis subjects and 20 healthy controls will complete lifestyle questionnaires and have blood drawn for microbiome analyses.
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Blood and BAL
10 sarcoidosis subjects, 10 healthy controls, and 10 subjects with non-sarcoid interstitial lung disease will complete lifestyle questionnaires and undergo blood sampling for microbiome analyses as well as bronchoscopy for bronchoalveolar lavage microbiome analyses.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbiome analysis
Time Frame: Baseline
|
To assess the microbiome profile in lung lavage fluid and peripheral blood of subjects
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measures of immunologic phenotype
Time Frame: Baseline
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To determine whether the immune cell profile of sarcoidosis patients differs from healthy controls and other interstitial lung disease patients in blood and BAL fluid
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Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eric S White, MD, University of Michigan
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
June 1, 2015
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
August 7, 2015
First Submitted That Met QC Criteria
August 10, 2015
First Posted (Estimate)
August 11, 2015
Study Record Updates
Last Update Posted (Actual)
June 5, 2017
Last Update Submitted That Met QC Criteria
June 2, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00095799
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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