Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON34153
Enrollment
218
Registered
2010-10-22
Start date
2011-06-14
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease inflammatory bowel disease ulcerative colitis

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Health related quality of life

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)