Skip to main content
OpenTrials
Completed

NCT Number: NCT03310164

Lung and Gut Microbiome in Chronic Obstructive Pulmonary Disease

Increasing evidence have implied that microbiota from airway and gut might be involved in the pathogenesis of chronic obstructive pulmonary disease (COPD). However, the cross-talk between respiratory and gastrointestinal microbiome in COPD is still undetermined. The study is aimed to investigate the interaction between lung and gut flora, and their role in the process of COPD.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

About this study

Despite the high prevalence of chronic obstructive pulmonary disease (COPD), there continues to be a large gap in our understanding of disease pathogenesis and mechanisms accounting for large variability in disease phenotype. Cigarette smoking is the principal cause of COPD, but only approximately 15% of adults with substantial tobacco exposure develop clinical COPD. Besides, bacterial colonization or infection is also considered as an important factor in COPD. There are very limited data from microbiome studies that suggest that respiratory and gastrointestinal microbiota may be involved in the pathogenesis of COPD. However, the cross-talk between between lung and gut microbiome, and their relationship with various clinical phenotypes of COPD. Here, we conducted 16S rRNA-based pyrosequencing to evaluate the link between the lung-gut axis and the clinical phenotypes of COPD, such as lung function, emphysema, symptoms, exacerbations, inflammation levels and metabolic features.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • males aged 40-80;
  • diagnosed with COPD according to the GOLD guidelines;
  • clinically stable patients without medication changes or exacerbation in two months;
  • smoking history of more than 10 pack years

Exclusion criteria

  • diagnosed with unstable cardiovascular diseases, significant renal or hepatic dysfunction or mental incompetence;
  • diagnosed with asthma, active pulmonary tuberculosis, diffuse panbronchiolitis, cystic fibrosis, clinically significant bronchiectasis, exacerbation of COPD or pneumonia in two months;
  • prescribed immunosuppressive medications.

Treatment and study plan

Primary outcomes

  1. Microbiota that can predict the progress of lung function

    Time frame: 6 months

    The study is aimed to investigate the relationship between the microbiota and the progress of lung function in COPD

Secondary outcomes

  1. Bacteria related to inflammatory factors

    Time frame: 6 months

    The association between microbiota and inflammatory factors from host is also investigated

  2. Bacteria related to metabolomics

    Time frame: 6 months

    The association between microbiota and metabolites from host is also investigated

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

The Relationship Between Lung and Gut Microbiome in Chronic Obstructive Pulmonary Disease

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 16, 2017
Registry last updated
Oct 16, 2017

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.

Published trials that share one or more normalized conditions with this study.