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Completed

NCT Number: NCT02392182

Lung HIV Microbiome Project (Michigan Site)

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Fiberoptic bronchoscopy

Other

All subjects will undergo a research fiberoptic bronchoscopy under moderate conscious sedation. There is no randomization

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Understanding the Lung Microbiome in HIV-Infected & HIV-Uninfected Individuals

Acronym: LHMP

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Mar 18, 2015
Registry last updated
Sep 16, 2016

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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