The Lung Microbiome in Sarcoidosis

NCT ID: NCT02520323

Last Updated: 2017-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-06-30

Brief Summary

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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

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Conditions

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Sarcoidosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Blood only

20 sarcoidosis subjects and 20 healthy controls will complete lifestyle questionnaires and have blood drawn for microbiome analyses.

Blood draw

Intervention Type OTHER

Questionnaires

Intervention Type BEHAVIORAL

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.

Blood draw

Intervention Type OTHER

Bronchoscopy

Intervention Type PROCEDURE

Questionnaires

Intervention Type BEHAVIORAL

Interventions

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Blood draw

Intervention Type OTHER

Bronchoscopy

Intervention Type PROCEDURE

Questionnaires

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Eric S. White, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric S White, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan Medical Center

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00095799

Identifier Type: -

Identifier Source: org_study_id

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