A primary objective of the study is to explore the underlying causes of the excess pneumonia risk in individuals living in the proximity of goat farms. Another objective is to study associations between long-term exposure to livestock farms and…
ID
Source
Brief title
Condition
- Other condition
- Respiratory tract infections
Synonym
Health condition
microbioom
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Control subjects, goat farmers (and patients)
• Pathogen detection in nasopharyngeal swab by multiplex PCR of 33 respiratory
pathogens (for details, see 8.3);
• Coxiella burnetii detection in nasopharyngeal swab by PCR;
• Oropharyngeal microbiota composition (16S rRNA sequencing);
• In subpopulation: nasopharyngeal/oropharyngeal virome and metagenome.
• serum response to SARS-CoV-2
Control group
• Pre-bronchodilator lung function;
• Respiratory symptoms (questionnaire).
Goat farmers
• Serology on farm related pathogens including Coxiella burnetii;
• Serology on farm related thermophilic bacteria as markers for
Hypersensitivity Pneumonitis (Extrinsieke Allergische Alveolitis).
Secondary outcome
Control group
• Atopic status, specific serum IgE to a panel of common inhalant allergens
namely: grass, tree, house dust mite, cat and dog;
Goat farmers
• Respiratory symptoms and exposure related to type of farm work
(questionnaire);
• Gut microbioata composition in faecal sample (16S rRNA sequencing);
Background summary
Exposures which originate from livestock farms, such as dust, (zoonotic)
microorganisms, endotoxins, and ammonia are associated with adverse health
effects in neighbouring residents. Several distinct signals have been found
recently: increased respiratory symptoms and medication use in chronic
obstructive pulmonary disease (COPD) patients living near livestock farms,
acute airway obstruction associated with elevated ammonia concentrations, and
an elevated risk for pneumonia near poultry and goat farms, accompanied by a
shift in the respiratory microbiome. The underlying causes have not been
unravelled.
We hypothesize that the excess pneumonia risk results from either inhalation of
potentially farm-related pathogens, or, alternatively, from other farm-related
exposures that lead to changes in the composition and diversity of the upper
respiratory tract microbiome and virome leading to excess pneumonia risk
through dysbiosis. These hypotheses will be studied in the so-called VGO-3
study. While awaiting the results of the VGO-3 study, 9 of the 12 provinces
have stopped issuing building permits for new and existing goat farms.
Study objective
A primary objective of the study is to explore the underlying causes of the
excess pneumonia risk in individuals living in the proximity of goat farms.
Another objective is to study associations between long-term exposure to
livestock farms and respiratory health, namely respiratory symptoms, atopic
sensitization, and lung function decline over a six-year follow-up period.
A secondary objective of the study is to to identify potential exposures
responsible for a decreased prevalence of asthma and allergy observed in
neighboring residents living close to a farm.
Study design
A cross-sectional analysis of the microbiome and virome of the oral and nasal
pharynx is performed in three different populations: (1) patients diagnosed
with pneumonia, living in an area with a high density of goat farms, (2) a
general population sample in a similar area (control group) and (3) employees
and owners of goat farms. Potential causative pathogens and shifts in the
respiratory microbiome and virome will be studied.
Study burden and risks
Burden: all subjects are requested to fill in a questionnaire and from all
subjects a swab from the nasal and the oral pharynx and a blood sample (1 * 10
mL) via venepuncture will be taken. In addition, participants in the control
group will perform a standard forced exhalatory spirometric lung function test.
From participants in the goat farmers group and a stool sample will be
collected. total time control subjects and goat farmers: 55 minutes.
Risks: This is an observational study, involving minimal risks for participants
(taking a single nasal and oral swab, a lung function test in 1600 control
subjects, and taking a blood sample in a subgroup of 150 participants).
Benefits: The study has no direct benefits for the participants. The study will
give relevant insight into the increased risk of pneumonia in areas with a high
density of (goat) farms as well as in environmental factors contributing to
this increased risk. Finally, the study will also contribute to a better
understanding of how (shifts in) the (respiratory) microbiome and virome
contribute to development of pneumonia and respiratory health in general.
Yalelaan 2
Utrecht 3584 CK
NL
Yalelaan 2
Utrecht 3584 CK
NL
Listed location countries
Age
Inclusion criteria
(Patient population: being diagnosed with pneumonia (ICPC-code R81) at
GP-office)
Control group: participated in VGO-1-study
Goat farmers: working on a goat farm
Exclusion criteria
Control group: no exclusion criteria. There are contra-indications for
performing lung function testing:
- Heart failure including heart attack in the last three months
- Chest or abdominal surgery in the past 3 months
- Ascending aortic aneurysm
- Haemoptysis
- A brain, ear or eye surgery in the past 1 month
- Usage of immunsuppressants/ chemotherapeutics
- Immunodeficiency
- Pregnancy (last trimester)
- Participants discomfort (diarrhea, vomiting, common cold)
Goat farmers: not able to communicate in Dutch
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL71068.041.19 |