To determine incidence, aetiology and course of gastroenteritis in case of hospitalisation with gastroenteritis. To gain insight in pathogen-specific duration, seriousness of the disease (including complications), and mortality. To investigate…
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence of gastroenteritis admissions.
Incidence of the following pathogens in patients hospitalised because of
gastroenteritis:
Bacteriology (RT-PCR): Salmonella, Shigella, Campylobacter, Yersinia,
shigatoxin producing E. coli (STEC), entero-aggregative E. coli (EAggEC),
enteropathogenic E. coli (EPEC) and Clostridium difficile
Virology (RT-PCR): rota-, adeno-, astro-, noro- and sapovirus
Parasitology (microscopy and ELISA): Cryptosporidium, Giardia and Dientamoeba
fragilis.
The course of illness per pathogen in patients hospitalised because of
gastroenteritis, including complications, chronic complaints and costs.
Secondary outcome
The DNA isolated from feces for detection of the pathogens will be used for
determining genetic polymorphisms in these patients groups. This study will
test genes involved in the specific immune response, in particular Th 1 genes,
genes involved in innate immunity, and genes involved in inflammatory
responses. The frequency of these polymorphisms will be compared to the
frequencies determined in population controls in earlier studies. Furthermore,
patients groups infected with different pathogens will be compared for
frequencies of the polymorphisms.
Background summary
Systematic and reliable information about incidence and aetiology of
gastroenteritis in the Netherlands is limited. Two large scaled epidemiologic
studies to gastroenteritis in the general population (Sensor) and the general
practitioner population (Nivel) yielded an estimation of 4.5 million episodes
of gastroenteritis per year in the Dutch population. In about 220,000 episodes,
a general practitioner was consulted. Information on hospital admissions for
gastroenteritis is limited to discharge diagnoses, using ICD-9 codes, recorded
by Stichting Prismant. These codes are too a-specific for distinction within
gastroenteritis. Furthermore, the pathogen causing the gastroenteritis remains
unknown in about two-third of the cases. Only a small percentage of patients
with gastroenteritis are hospitalised, but the costs of treatment of this group
of patients is estimated to be 41 million euros.
Study objective
To determine incidence, aetiology and course of gastroenteritis in case of
hospitalisation with gastroenteritis. To gain insight in pathogen-specific
duration, seriousness of the disease (including complications), and mortality.
To investigate seasonal influences, data collection will comprise one complete
year.
Study design
Patient will be invited to the study by a physician/nurse of the ward where the
patient was admitted with gastroenteritis.
A control will be recruited on the same ward as the participating patient.
Two feces samples will be collected (besides standard diagnostics of the
hospital) and tested for a fixed panel of pathogens.
Patient and control will be asked to fill in a questionnaire before discharge
from the hospital. The questionnaire contains questions about (medical)
background and possible risk factors.
The physician/nurse is asked to provide some medical data of the patient, using
a questionnaire. The results of the standard diagnostics of the patient will be
retrieved.
A second questionnaire will be send to the patient and the control two to three
months after discharge from the hospital. This second questionnaire contains
questions about complications and chronic complaints.
Patients and or controls mentioning complications or chronic complaints on the
second questionnaire will receive a third questionnaire about six months after
discharge from the hospital. The third questionnaire again contains questions
about complications and chronic complaints.
Study burden and risks
The participants are asked to complete two or three questionnaires. Total
length: 15 minutes for the first questionnaire and 5-10 minutes for the second
and third questionnaire. Furthermore, two stool samples are asked at the start
of the study.
Postbus 20350
2500 EJ DEN HAAG
NL
Postbus 20350
2500 EJ DEN HAAG
NL
Listed location countries
Age
Inclusion criteria
A person with complaints of diarrhoea and or vomiting, who is being submitted to the hospital
Exclusion criteria
Not having diarrhoea or vomiting complaints, having had diarrhoea or vomiting complaints in the two weeks before the current episode, being younger than 2 weeks
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 | NL20258.041.07 |