Faecal calprotectin as a diagnostic test for IBD in children in primary care

Completed

• Conditions: Crohn's disease; inflammatory bowel disease; ulcerative colitis; 10017969

• Registration Number: NL-OMON34153
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 218

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

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Sensitivity, specificity and ROC-curve of faecal calprotectin. Test results of<br /><br>faecal calprotectin will be compared to a diagnosis of IBD after 12 months<br /><br>follow-up. Outcome of care defined as optimal care, delay of diagnosis, and<br /><br>unnecessary endoscopy are secondary endpoints. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Health related quality of life </p><br>