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Completed

NCT Number: NCT02520323

The Lung Microbiome in Sarcoidosis

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.

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Key information

Conditions

Sarcoidosis Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lymphatic Diseases Lymphoproliferative Disorders

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Draw

Other

Bronchoscopy

Procedure

Questionnaires

Behavioral

Primary outcomes

  1. Microbiome analysis

    Time frame: Baseline

    To assess the microbiome profile in lung lavage fluid and peripheral blood of subjects

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 11, 2015
Registry last updated
Jun 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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