To assess the (additional) diagnostic value of faecal calprotectin in children, age 4-18 years, with symptoms suggestive for IBD, in a primary and secondary/tertiary care setting.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sensitivity, specificity and ROC-curve of faecal calprotectin. Test results of
faecal calprotectin will be compared to a diagnosis of IBD after 12 months
follow-up. Outcome of care defined as optimal care, delay of diagnosis, and
unnecessary endoscopy are secondary endpoints.
Secondary outcome
Health related quality of life
Background summary
Each year approximately 250 children in the Netherlands are diagnosed with
inflammatory bowel disease (IBD: Crohn*s disease and ulcerative colitis).
Symptoms of IBD can be atypical and overlap with symptoms of functional bowel
disease. Diagnostic delay can have serious consequences, such as irreversible
growth delay and negative effects on sexual development. Final diagnosis of IBD
is based on invasive diagnostic tests, namely endoscopy under full anaesthesia.
A simple and non-invasive screening test, suitable for children in primary
care, that would both prevent diagnostic delay and unnecessary endoscopies,
would be very helpful. Previous studies have shown that measuring faecal
calprotectin is an easy, non-invasive and reliable test. However these studies
were performed in highly selective patient groups in secondary and tertiary
care settings not representing the care setting where this test is most needed,
namely primary care.
Study objective
To assess the (additional) diagnostic value of faecal calprotectin in children,
age 4-18 years, with symptoms suggestive for IBD, in a primary and
secondary/tertiary care setting.
Study design
cohort study with a follow-up period of one year.
Study burden and risks
In this study we apply standard clinical practice, as we adhere to the CBO
guideline *inflammatory bowel disease in children* . However, questionnaires
and calprotectin measurements are not included in this guideline. Therefore,
completing questionnaires and collecting a stool sample are regarded as an
extra time investment. Benefits for participants of this study are being well
monitored on symptoms, possible earlier detection of IBD. Good clinical care is
guaranteed.
Postbus 197
9700 AD Groningen
NL
Postbus 197
9700 AD Groningen
NL
Listed location countries
Age
Inclusion criteria
1.Age 4-18 years
2.Diarrhoea >= 2 weeks or >= 2 episodes of diarrhoea in the past 6 months or recurrent abdominal pain (>= 2 episodes of abdominal pain in the past 6 months)
3.Informed consent
Exclusion criteria
1.Previously established diagnosis of chronic organic gastrointestinal disease
2.A complete evaluation in the past year for abdominal symptoms, including endoscopy
3.Chronic use of antibiotics, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or oral corticosteroids.
4.Difficulty in understanding questionnaires due to cognitive impairment or language problems
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 | NL32660.042.10 |