The overall goal of this study is to get an up-to-date data on the incidence, disease burden, and etiology of gastrointestinal infections in the general practitioner population. More specific goals:1. Determine the incidence of gastrointestinal…
ID
Source
Brief title
Condition
- Gastrointestinal infections
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Incidence of gastrointestinal infections in the general practitioner
population and the general population per 1.000 person-years
- Prevalence per bacterial, viral and parasitic pathogen in persons visiting
the general practitioner with a gastrointestinal infection, and the general
population
- Risk factors for gastrointestinal infections, as well as pathogen-specific
risk factors, in the general practitioner population and the general population
- Factors, such as severity of symptoms, that differentiate between persons for
which diagnostic testing is requested by the general pracittioner and those for
which diagnostics is not requested
Secondary outcome
Patients that gave consent to be approached again for future studies could
provide insight in the development of sequelae following gastrointestinal
infections. The feces databank provides opportunities for gut microbiome
research.
Background summary
The last study on the etiology and epidemiology of gastro-intestinal infections
in the general practitioners population was conducted in the 90s and is likely
not representative for the current situation. However, it is still the basis
for the NHG-standaard Acute diarrhea and burden estimations. Moreover, the
diagnostics have changed substantially since the 90s.
Study objective
The overall goal of this study is to get an up-to-date data on the incidence,
disease burden, and etiology of gastrointestinal infections in the general
practitioner population.
More specific goals:
1. Determine the incidence of gastrointestinal infections in the general
population population
2. Determine the proportion of gastrointestinal infections in the general
population population for which diagnostic testing is requested
3. Determine the incidence of multiple bacteria, virusses and parasites in
persons visiting the general practitioner with a gastrointestinal infection,
and compare it with the incidence in the general population
4. Determine (pathogen specific) risk factors that differentiate between
persons with gastrointestinal infections for which diagnostic testing is
requested by the general pracittioner and those for which diagnostics is not
requested
Optional:
5. Follow-up investigation on sequelae after gastrointestinal infections
6. Build a fecesbank for (future) pathogen discovery and microbiome research
Study design
This is a prospective case-controle study on gastro-intestinal infections in
the general practitioners population. Patients visiting the general
practitioner with a gastrointestinal infections and controls in the general
population will be asked to collect two fecal samples for bacterial, viral and
parasitic diagnostics. They are also asked to fill in a questionnaire
containing questions about their household (e.g. number of persons), symptoms
(type of symptoms, severity and duration), medicine use, sick leave,
comorbidities and exposure (e.g. travelling abroad, animal contact).
Study burden and risks
Participation is voluntary. Participants will be asked to fill two tubes with
feces and complete a questionnaire. Filling in the questionnaire takes about 15
minutes. Patients in the general practitioners population can provide consent
to inform their general pracitioners with the results of the diagnostics tests.
It is possible that pathogens are found that can explain so far unexplained
symptoms, providing the general practitioner with opportunities for treatment.
The risk for participants is believed to be low, because participants only have
to provide two fecal samples and complete a questoinnaire. This application
therefore requests exemption for test subject insurance application in the
cover letter
.
Antonie van Leeuwehoeklaan 9
Bilthoven 3720 BA
NL
Antonie van Leeuwehoeklaan 9
Bilthoven 3720 BA
NL
Listed location countries
Age
Inclusion criteria
Patients:
Patients presenting at the general practitioners with the following ICPC codes:
- Diarrhea(ICPC code D11) with a suspected infectious cause
- Infectious diarrhea/dysenteriae (International Classification of Primary Care
[ICPC] code D70)
- Presumed gastro-intestinal infection (ICPC code D73).
Controls:
Everyone who is registered in the population registry
Exclusion criteria
Patients:
A person is excluded if he/she already adhered to the inclusion criteria in the
three weeks before onset date OR if current complaints started more than 14
days ago
Controls:
There are no exclusion criteria
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 | NL72240.041.19 |