Differences in the gastrointestinal microbiome signature in chronic obstructive pulmonary disease (COPD)

Not Applicable

Recruiting

• Conditions: Microbiome; Chronic obstructive pulmonary disease (COPD); Respiratory - Chronic obstructive pulmonary disease

• Registration Number: ACTRN12614001286639
• Lead Sponsor: Peter Wark

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-09
• Last Update Posted: 3 February 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Adults > age 40 years with COPD GOLD grade 2 and above, confirmed by incompletely reversible airflow obstruction (post bronchodilator forced expiratory volume in one second (FEV1) <80% predicted and forced expiratory ratio (FER) <0.7 or physician confirmed COPD in patients with a reduced forced vital capacity (FVC)), and stable disease with no recent respiratory infection, acute exacerbation, or change in maintenance therapy in the previous 4 weeks.

Participants will be classified according to their GOLD quadrant (A, B, C, D).

Healthy controls subjects will be adults >40 years recruited from the Hunter Medical Research Institute volunteer register. Participants will have no history of cardiac or respiratory disease and have normal lung function measured by spirometry. In addition they will not have experienced a respiratory tract infection in the previous four weeks, nor used antibiotics.

Exclusion Criteria

Participants will be excluded if they have received treatment with an antibiotic or oral prednisone in the last 4 weeks. This includes the regular use of antibiotics in subjects with COPD. In addition subjects with a previous history of gastrointestinal disease (GI disease), will be excluded. Subjects will also be excluded if they have a history of significant abdominal pain, bloating or diarrhoea in the previous 4 weeks. The study does not exclude current or ex-smokers.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The microbiome of persons with COPD will be compared to those without COPD. This will be done by extracting DNA from fecal samples which will be then PCR amplified for pyrosequencing of 16S ribosomal genes for bacterial taxa identification. The resulting microbiome profiles will be correlated to disease severity by means of inflammatory markers as determined by serum tests and to spirometry results.[Baseline only (cross-sectional study)]

Secondary Outcome Measures

Name	Time	Method
/A[N/A]