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Trial registered on ANZCTR


Registration number
ACTRN12614001286639
Ethics application status
Approved
Date submitted
26/11/2014
Date registered
9/12/2014
Date last updated
26/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Differences in the gastrointestinal microbiome signature in chronic obstructive pulmonary disease (COPD)
Scientific title
Differences in the gastrointestinal microbiome signature in patients with chronic obstructive pulmonary disease (COPD) compared to healthy people
Secondary ID [1] 285743 0
Nil
Universal Trial Number (UTN)
Trial acronym
COPooD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease (COPD) 293627 0
Microbiome 293628 0
Condition category
Condition code
Respiratory 293923 293923 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Specimen collection / observational only (no intervention). Patients will be asked to undergo spirometry and will have blood and feces collected. Spirometry and blood collection will occur at assessment and the procedures should last no longer than 30 minutes. Feces will be collected by the participant at his/her own home and stored in their freezer until it can be brought to the clinic.
Intervention code [1] 290699 0
Not applicable
Comparator / control treatment
Controls will be healthy persons without COPD. Spriometry will be performed and blood and feces collected.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293696 0
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.
Timepoint [1] 293696 0
Baseline only (cross-sectional study)
Secondary outcome [1] 311615 0
N/A
Timepoint [1] 311615 0
N/A

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/01/2015
Actual
4/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3215 0
John Hunter Hospital Royal Newcastle Centre - New Lambton

Funding & Sponsors
Funding source category [1] 290313 0
Government body
Name [1] 290313 0
National Health and Medical Research Council (NHMRC)
Country [1] 290313 0
Australia
Funding source category [2] 290314 0
Other
Name [2] 290314 0
Hunter Medical Research Institute (HMRI)
Country [2] 290314 0
Australia
Primary sponsor type
Individual
Name
Peter Wark
Address
Department of Respiratory and Sleep Medicine
Vaccines, Infection, Viruses & Asthma (VIVA)
Hunter Medical Research Institute
Lot 1 Kookaburra Circuit
New Lambton Heights
NSW 2305
Country
Australia
Secondary sponsor category [1] 289030 0
Individual
Name [1] 289030 0
Philip Hansbro
Address [1] 289030 0
The University of Newcastle
Immunology Hunter Medical Research (HMRI) Building
University Drive
Callaghan NSW 2308
Country [1] 289030 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292020 0
Hunter New England
Ethics committee address [1] 292020 0
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 292020 0
Australia
Date submitted for ethics approval [1] 292020 0
Approval date [1] 292020 0
14/10/2014
Ethics approval number [1] 292020 0
14/08/20/3.02

Summary
Brief summary
Chronic obstructive pulmonary disease (COPD) affects approximately 7.5% of the Australian population over 40 years of age. Many people with COPD suffer periodic exacerbations that can make them feel much worse. We have effective treatments for managing the symptoms of COPD, but they do not cure the disease.

The “microbiome” is the term given to all the microorganisms, such as bacteria, that live on and in our body. There are at least 10 times as many bacterial cells than human cells in the gut alone. All these microbes live in harmony with our body and we benefit from them being there; for example, they can produce vitamins that we need and can ward off pathogenic microbes that might do us harm. There are many ways in which the “health” of our microbiome can be affected.

We have found that the number and species of bacteria in the microbiome of mice with COPD is different to that in mice without COPD. The purpose of this study is to determine if the same is true in people. The bacteria that are different might serve either protective or negative roles in terms of health.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53078 0
Prof Peter Wark
Address 53078 0
Department of Respiratory and Sleep Medicine
Vaccines, Infection, Viruses & Asthma (VIVA)
Hunter Medical Research Institute
Lot 1 Kookaburra Circuit
New Lambton Heights, NSW 2305
Country 53078 0
Australia
Phone 53078 0
+61 2 40420110
Fax 53078 0
Email 53078 0
[email protected]
Contact person for public queries
Name 53079 0
Peter Wark
Address 53079 0
Department of Respiratory and Sleep Medicine
Vaccines, Infection, Viruses & Asthma (VIVA)
Hunter Medical Research Institute
Lot 1 Kookaburra Circuit
New Lambton Heights, NSW 2305
Country 53079 0
Australia
Phone 53079 0
+61 2 40420110
Fax 53079 0
Email 53079 0
[email protected]
Contact person for scientific queries
Name 53080 0
Philip Hansbro
Address 53080 0
The University of Newcastle
Immunology Hunter Medical Research Institute (HMRI) Building
University Drive
Callaghan NSW 2308
Country 53080 0
Australia
Phone 53080 0
+61 2 40420187
Fax 53080 0
Email 53080 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6411Study protocol   



Results publications and other study-related documents

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