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Lung HIV Microbiome Project (Michigan Site) (LHMP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02392182
Recruitment Status : Completed
First Posted : March 18, 2015
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):
Jeffrey L. Curtis, University of Michigan

Brief Summary:

In its original phase, this cohort study recruited subjects who were either HIV-positive or HIV-negative healthy controls, to analyze the community structure of the lung microbiome. Original recruitment was planned to occur both at the University of Michigan Medical Center and clinics, and at VA Ann Arbor Healthcare System.

Enrollment for the original cohort is completed, and all current activity of this project is occurring at VA Ann Arbor, where both Veteran subjects and non-Veteran subjects are eligible to participate. This study is currently recruiting only healthy HIV-negative subjects. Participation, described below, involves a research bronchoscopy procedure.


Condition or disease Intervention/treatment
Healthy Participants Tobacco Use Disorder Human Microbiome Other: Fiberoptic bronchoscopy

Detailed Description:
This is a non-interventional cohort study with single time point cross-sectional comparisons and longitudinal analyses, with the primary study aims of: evaluating how the immune deficiency associated with HIV infection influences the lung microbiome and lung function, and evaluating changes in lung microbiota over time. The study also aims to characterize the microbiome of the lower respiratory tract, determine the relationship between the lower respiratory Microbiome and the upper respiratory and gastrointestinal tract microbiomes, evaluate the influence of smoking on the microbiome compared with the influence of smoking on pulmonary function and respiratory systems, and to evaluate how Pneumocystis infection influences HIV-infected and HIV-uninfected individuals.

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Study Type : Observational
Actual Enrollment : 59 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Understanding the Lung Microbiome in HIV-Infected & HIV-Uninfected Individuals
Study Start Date : October 2009
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
healthy volunteers
no intervention to be administered in this observational study, although all participants will undergo fiberoptic bronchoscopy.
Other: Fiberoptic bronchoscopy
All subjects will undergo a research fiberoptic bronchoscopy under moderate conscious sedation. There is no randomization




Primary Outcome Measures :
  1. Lung bacterial microbiome community structure [ Time Frame: at time of bronchoscopy ]
    biological samples will be analyzed by culture-independent microbiological and bioinformatic techniques to determine the constituent members of the bacterial microbiome at each sampled site, to the level of "operational taxonomic unit" at 97% similarity to published sequences.


Biospecimen Retention:   Samples Without DNA
Oral rinse Nasal swap Bronchoalveolar lavage


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy individuals with no more than mild treated chronic diseases that would not preclude a research bronchoscopy under moderate conscious sedation. Both never-smokers and active smokers are welcome.
Criteria

Inclusion Criteria:

  • Negative HIV testing (by ELISA) during initial study visit
  • No signs of respiratory infection at enrollment, such as: fever; recent change in quantity of quality of sputum; chest pain; recent change in shortness of breath or exertional activity
  • Willing and able to sign the informed consent document
  • If female of child-bearing potential, negative pregnancy test during initial study visit

Exclusion Criteria:

  • Pregnancy
  • Signs or symptoms of respiratory infection at enrollment
  • Unwilling or unable to sign the informed consent document
  • Unstable heart disease
  • Other systemic disease and unlikely to survive at least 2 years
  • Mental incompetence
  • Participation in another interventional protocol within the last 6 weeks
  • Use of antibiotics for a lung infection within the last 4 weeks
  • Renal Failure (creatinine >3)
  • Child's Class C Cirrhosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02392182


Locations
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United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Jeffrey L. Curtis, MD Professor of Internal Medicine & Staff Physician, VA Ann Arbor
Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jeffrey L. Curtis, Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT02392182    
Other Study ID Numbers: Curtis 0036
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: deidentified data and biological specimens deposited with NIH BioLNCC
Keywords provided by Jeffrey L. Curtis, University of Michigan:
lung
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders