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

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Medical Center

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.
Other: Blood draw
Behavioral: Questionnaires
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.
Procedure: Bronchoscopy
Other: Blood draw
Behavioral: Questionnaires

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
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measures of immunologic phenotype
Time Frame: 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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

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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