Lung and Gut Microbiome in Chronic Obstructive Pulmonary Disease

NCT03310164 | Completed

• 1 other identifier: HB55474
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Bacteria related to inflammatory factors

  6 months

• Bacteria related to metabolomics

  6 months

Study Arms (2)

COPD

Smokers with clinically stable chronic obstructive pulmonary disease (COPD)

healthy control

Age-matched subjects without chronic obstructive pulmonary disease (COPD)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Throat swab, induced sputum, bronchoalveolar lavage fluid (BALF) and faeces

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief in Department of Respiratory Medicine

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: October 16, 2017
• Study Start: June 15, 2014
• Primary Completion: February 15, 2016
• Study Completion: February 15, 2016
• Last Updated: October 16, 2017

Record last verified: 2017-10

Locations

CN (1)