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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02520323
Date of registration: 07/08/2015
Prospective Registration: No
Primary sponsor: University of Michigan
Public title: The Lung Microbiome in Sarcoidosis
Scientific title: The Lung Microbiome in Sarcoidosis
Date of first enrolment: June 2015
Target sample size: 21
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02520323
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Eric S White, MD
Address: 
Telephone:
Email:
Affiliation:  University of Michigan
Key inclusion & exclusion criteria

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.



Age minimum: 30 Years
Age maximum: 60 Years
Gender: All
Health Condition(s) or Problem(s) studied
Sarcoidosis
Intervention(s)
Other: Blood draw
Procedure: Bronchoscopy
Behavioral: Questionnaires
Primary Outcome(s)
Microbiome analysis [Time Frame: Baseline]
Secondary Outcome(s)
Measures of immunologic phenotype [Time Frame: Baseline]
Secondary ID(s)
HUM00095799
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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