Lung and Gut Microbiome in Chronic Obstructive Pulmonary Disease

The Relationship Between 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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Clinically stable patients with COPD and controls without COPD are enrolled.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
COPD; Smokers with clinically stable chronic obstructive pulmonary disease (COPD)
healthy control; Age-matched subjects without chronic obstructive pulmonary disease (COPD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiota that can predict the progress of lung function	The study is aimed to investigate the relationship between the microbiota and the progress of lung function in COPD	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacteria related to inflammatory factors	The association between microbiota and inflammatory factors from host is also investigated	6 months
Bacteria related to metabolomics	The association between microbiota and metabolites from host is also investigated	6 months

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2014
• Primary Completion (Actual): February 15, 2016
• Study Completion (Actual): February 15, 2016

Study Registration Dates

• First Submitted: October 9, 2017
• First Submitted That Met QC Criteria: October 10, 2017
• First Posted (Actual): October 16, 2017

Study Record Updates

• Last Update Posted (Actual): October 16, 2017
• Last Update Submitted That Met QC Criteria: October 10, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: HB55474

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No