The generic objective of the study is to explore associations between exposure to livestock farms and potential health effects. This study will focus on 1) respiratory health effects, 2) Livestock associated infections (zoonoses), 3) Carriage of…
ID
Source
Brief title
Condition
- General system disorders NEC
- Hepatobiliary neoplasms malignant and unspecified
- Congenital respiratory tract disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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).
Background summary
Since several years, there is more attention to health of residents living near
livestock farms. Discussions about potential public health risks accelerate due
to the Q-fever epidemic and the increasing number of livestock-related
antibiotic resistant bacteria (for example MRSA- and ESBL-bacteria). In 2011 a
explorative study was conducted to look at the association between GP
registered health effects and distance to livestock farms in combination with
measured concentration of airborne fine dust and (parts of ) bacteria nearby
livestock farms (Heederik & Ijzermans 2011). Results were a motivation for a
more extensive study to look at exposure of residents living near livestock
farms and health risks of this exposure.
Study objective
The generic objective of the study is to explore associations between exposure
to livestock farms and potential health effects. This study will focus on 1)
respiratory health effects, 2) Livestock associated infections (zoonoses), 3)
Carriage of resistant micro-organisms.
Primary Objectives are:
Respiratory health effects
- To study associations between exposure to livestock farm emissions and
respiratory effects including symptoms and lung function (spirometry) in a
population sample of individuals living at varying distances of livestock
farms. In a subsample of individuals with COPD, changes in lung function,
respiratory symptoms, and respiratory medication use over time in association
with temporal changes in farm exposures will be studied. The composition of
nasopharyngeal and oropharyngeal microbiota will be compared between COPD
patients and healthy subjects with a low or high density of animal farms around
their homes.
Livestock associated infections
- To assess (previous) exposure to several livestock-farming associated
pathogens by studying serological responses to these micro-organisms in a
population sample of individuals living at varying distances to livestock farms.
Carriage of resistant micro-organisms
- To determine the prevalence of carriage of livestock-associated resistant
microorganisms in a population sample of individuals living at varying
distances of animal farms.
- To study associations between livestock related exposures to resistant
microorganisms and human carriage of these microorganisms in a population
sample of individuals living at varying distances of animal farms.
Persistence of ESBL-forming bacteria
The primary objectives are:
- To study the persistence of ESBL-forming bacteria in the general population
over a 5-month period.
Persistence of MRSA and the possible association with horse-contact:
- To study the persistence of MRSA in the general population over a 1-2 year
period.
Study design
Observational cross-sectional study with longitudinal follow-up studies and a
panel study in different subgroups of participants.
Study burden and risks
Participants in the cross-sectional study will be asked to visit a research
center. The use of temporary research centers sets the maximum travel distance
for each participant to 10 km. During the visit to the research center, a
standard forced exhalatory spirometric lung function test will be conducted,
blood (total 25 mL) will be collected via venapuncture, a nasal swab and a
nasal and buccal brush will be taken. The visit (excluding travel time) will
take around 45 minutes of time. Prior to the survey visit, participant will
receive a questionnaire and sampling instructions for a faecal sample. Faecal
samples will be taken by the participants at home and sent to the laboratory by
mail. Completing the questionnaire takas approximately 30 minutes of time.For
participants who are not able to visit the research center (for instance
physical disabled participants), a nurse practitioner will visit them at their
home address for the lung function test, blood sampling, nasal swab, and nasal
and buccal brush.
In total 125 ESBL positive participants and 250 ESBL negative participants will
be selected from the cross-sectional study and included in the ESBL
longitudinal follow-up study. In total five rectal swabs will be asked from the
participants with an interval of one month. Rectal swabs will be taken by the
participants at home and send to the laboratory by mail. Additional,
participants will be asked to complete a short questionnaire (2 minutes).
In total 13 MRSA positive and 52 MRSA negative participants will be invited
from the cross-sectional study to participate to the MRSA case control study.
Participants will be asked to take one nose-swab and one short questionnaire
and to send to the laboratory by mail. This will take in total 15 minutes of
time.
Participants of the airway microbiome study (100 COPD patients and 200
controls) will be visited three times at their home by a research worker, a
nasal and throat swab will be taken during each visit. Participants will fill
out a short questionnaire. The home visit takes 10 minutes of time.
Participants of the COPD-panel study will be visited three times. The first
visit will takes 45 minutes of time and the second and third visit will take 30
minutes of time. The COPD patients will be asked to measure peak flow twice a
day, to complete the diary daily, and to fill out an additional short
questionnaire every week, during the study period of 3 months. This will take
10 minutes of time per day.
yalelaan 2
Utrecht 3584 CM
NL
yalelaan 2
Utrecht 3584 CM
NL
Listed location countries
Age
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
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
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 | NL45307.041.13 |