The Lung Microbiome in Sarcoidosis

Sarcoidosis Clinical Trial

Official title:

The Lung Microbiome in Sarcoidosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02520323
• Other study ID #: HUM00095799
• Status: Completed
• Phase: N/A
• First received: August 7, 2015
• Last updated: June 2, 2017
• Start date: June 2015
• Est. completion date: June 2017

Study information

• Verified date: June 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sarcoidosis

Intervention

Other:
• Blood draw

Procedure:
• Bronchoscopy

Behavioral:
• Questionnaires

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiome analysis	To assess the microbiome profile in lung lavage fluid and peripheral blood of subjects	Baseline
Secondary	Measures of immunologic phenotype	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