airway microbioom Asthma carriage of resistant-bacteria COPD (Chronic Obstructive Pulmonary Disease) zoonoses
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Resident of the province of Noord-Brabant or the northern area of Limburg covered by the participating GP*s (General Practitioner) of the GP-network of NIVEL - Aged between 18 and 70 years - Living in a rural area - Giving consent on the screening questionnaire to be contacted for follow-up. Longitudinale ESBL and MRSA follow-up study: -Participants who tested ESBL-positive during the cross-sectional study. In addition, per each invited ESBL positive participant two participants who tested ESBL-negative will be selected at random from the same research center. -Participants who tested positive for MRSA during the cross-sectional study. And per individual invited participant, four controls (who tested negative for MRSA) will be invited. COPD panel study and airway microbiome study: COPD patient: - Prior given consent to be contacted for follow-up during the cross-sectional study - Airflow limitation (post-bronchodilator fixed ratio of FEV1/FVC less than 0.7) Control subject: - Prior given consent to be contacted for follow-up during the cross-sectional study - For each COPD patient, 2 controls will be selected at random from the same research center.
Exclusion criteria
Exclusion criteria: Exclusion criteria Cross-sectional study: If a potential subject meets one of the contraindications for spirometry, the subject will be excluded for sub-study: *A. Respiratory effects* (the subject can still participate to other parts of the study). Absolute contra-indications spirometry -Heart attack in the last three months -Chest or abdominal surgery in the past 3 months -Ascending aortic aneurysm -Heamopthysis -A brain, ear or eye surgery in the past 1 month -Pregnancy (last trimester);Relative contra-indications -Patient discomfort (diarrhea, vomiting, common cold) If a potential subject meets one of the contraindications for reversibility test, the subject will be excluded from the reversibility test. Absolute contra-indications reversibility test: -Use of medication that can be influenced by salbutanol or can influence the effect of salbutamol -Pregnancy (second trimester), -Breastfeeding -Diabetes -Hypertension Relative contra-indication reversibility test: -Use of salbutamol within 4 hours a prior of the reversibility test Longitudinal ESBL follow-up - Having COPD - Being C. difficile positive;MRSA case-control study: -participant of the COPD panel study -Participant of the ESBL longitudinal study;COPD panel study and airway microbiome study: COPD patient: - Current smoker Control subject: - Current smoker - Airflow limitation (post-bronchodilator fixed ratio of FEV1/FVC less than 0.7), or reversibility >12% - Self-reported COPD or asthma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| inflammatory responses by peripheral blood cells (in sub-population n = 350) and respiratory symptoms (questionnaire). -Zoonoses: antibodies to (respiratory) zoonotic pathogens and other pathogens that are potentially associated with livestock farming. -Resistant microorganisms: nasal MRSA carriage, ESBL-producing bacteria and Clostridium difficile from faecal samples. Longitudinal ESBL follow-up study (n= 25 ESBL positive participants and 25 controls): In total 25 participants who tested positive for ESBL during the cross-sectional study, will be asked for repeated samples (rectum swab). In total, five repeated samples will be asked with an interval of one month. Primary study parameter: -Carriage of ESBL-producing bacteria MRSA case-control study (n=13 MRSA positive participants and 52 controls): In total 13 MRSA positive and 52 MRSA negative participants of the cross-sectional study, will be asked for one repeated sample (neus-swab). Primary study parameter: -Carriage of MRSA Airway microbioom study (n= 100 COPD patients and 200 controls): Participants will be visited at home three times, a nasal and throat swab will be taken during each visit. Primary study parameter: - the composition of nasopharyngeal and oropharyngeal microbiota COPD panel study: In total 100 COPD patients will register during three months; twice daily peak-flow, daily dairy and a weekly questionnaire. Primairy study parameterL - Daily peak-flow - Daily respiratory symptoms and medication usage (dairy) For all these parameters results of the air sampling and GP medical records will be used to study relationships between measured emission and health effects, also taking into account distance to farming in general. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cross-sectional study (n=2 500) -Single nucleotide polymorphisms (SNPs)(EDTA blood tubes) in candidate genes for respiratory and allergic disease. This will enable the evaluation of potential genetic susceptibility and gene-environment interactions at a later stage (additional funding is required). -DNA methylation (nasal and buccal mucosa cell DNA) in asthma candidate gene loci will potentially be measured by a pyrosequencing assay (at a later stage; additional funding is required). | — |
Countries
Netherlands