The Lung Microbiome in Sarcoidosis

Completed

• Conditions: Sarcoidosis
• Interventions: Other: Blood draw; Procedure: Bronchoscopy; Behavioral: Questionnaires

• Registration Number: NCT02520323
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-08-07
• Study First Submitted QC: 2015-08-10
• Study First Posted: 2015-08-11
• Status Verified: 2017-06
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Last Update Submitted: 2017-06-02
• Last Update Posted: 2017-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Blood only	Blood draw	20 sarcoidosis subjects and 20 healthy controls will complete lifestyle questionnaires and have blood drawn for microbiome analyses.
Blood and BAL	Questionnaires	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.
Blood and BAL	Blood draw	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.
Blood and BAL	Bronchoscopy	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.
Blood only	Questionnaires	20 sarcoidosis subjects and 20 healthy controls will complete lifestyle questionnaires and have blood drawn for microbiome analyses.

Primary Outcome Measures

Name	Time	Method
Microbiome analysis	Baseline	To assess the microbiome profile in lung lavage fluid and peripheral blood of subjects

Secondary Outcome Measures

Name	Time	Method
Measures of immunologic phenotype	Baseline	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

Trial Locations

Locations (1)

University of Michigan Medical Center; 🇺🇸 Ann Arbor, Michigan, United States