Lung and Gut Microbiome in Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03310164
• Other study ID #: HB55474
• Status: Completed
• Phase: N/A
• First received: October 9, 2017
• Last updated: October 10, 2017
• Start date: June 15, 2014
• Est. completion date: February 15, 2016

Study information

• Verified date: October 2017
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 15, 2016
• Est. primary completion date: February 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Bacteria related to inflammatory factors	The association between microbiota and inflammatory factors from host is also investigated	6 months
Secondary	Bacteria related to metabolomics	The association between microbiota and metabolites from host is also investigated	6 months