SarcoidosisNCT02520323
The Lung Microbiome in Sarcoidosis
An observational study of Sarcoidosis, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- Blood draw, Bronchoscopy and Questionnaires
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Potential subjects will be patients with sarcoidosis (involving any organ system), with non-sarcoid interstitial lung disease, and healthy controls.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
About this study
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.
- Conditions
- Sarcoidosis
- Being tested
- Blood draw, Bronchoscopy, Questionnaires
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawOther
BronchoscopyProcedure or surgery
QuestionnairesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Blood only | 20 sarcoidosis subjects and 20 healthy controls will complete lifestyle questionnaires and have blood drawn for microbiome analyses. Receives: 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. Receives: Other: Blood draw; Procedure: Bronchoscopy; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome analysis
To assess the microbiome profile in lung lavage fluid and peripheral blood of subjects
Measured: Baseline
Secondary outcomes (1)
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric S. White, MD, University of Michigan
- Investigators
- Eric S White, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520323
- Sponsor's protocol ID
- HUM00095799
- Status last verified
- Jun 2017
- First submitted
- 7 Aug 2015
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Lung Microbiome in Sarcoidosis
- ClinicalTrials.gov ID
- NCT02520323
- Acronym / sponsor ID
- HUM00095799
- Conditions
- Sarcoidosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 11 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood only | – | Other: Blood draw, Behavioral: Questionnaires20 sarcoidosis subjects and 20 healthy controls will complete lifestyle questionnaires and have blood drawn for microbiome analyses. |
| Blood and BAL | – | Other: Blood draw, Procedure: Bronchoscopy, Behavioral: Questionnaires10 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Potential subjects will be patients with sarcoidosis (involving any organ system), with non-sarcoid interstitial lung disease, and healthy controls.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood draw | Other | Blood and BAL, Blood only |
| Bronchoscopy | Procedure or surgery | Blood and BAL |
| Questionnaires | Behavioural | Blood and BAL, Blood only |
Primary outcome
Microbiome analysis
Time frame: Baseline
To assess the microbiome profile in lung lavage fluid and peripheral blood of subjects
1 secondary outcome
Measures of immunologic phenotype
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric S White, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoidosis, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome analysis (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2017.