Status:
COMPLETED
Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Cisbio Bioassays
Conditions:
Abdominal Pain
Rectal Bloodloss
Eligibility:
All Genders
6-18 years
Brief Summary
RATIONALE: A substantial proportion of children and teenagers with suspected inflammatory bowel disease (IBD) referred for endoscopy do not have the disease. The investigators designed a clinical dec...
Detailed Description
DESIGN: A prospective diagnostic accuracy study in several outpatient clinics for general paediatrics and several tertiary care hospitals in the Netherlands and Belgium. STUDY POPULATION: Eligible ...
Eligibility Criteria
Inclusion
- Eligible patients are those aged between 6 and 18 years with at least one of the following criteria:
- Persistent diarrhea (at least 4 wks)
- Recurrent abdominal pain with diarrhea (at least 2 episodes in 6 months)
- Rectal bloodloss
- Peri-anal disease
- OR at least two of the following criteria:
- Involuntary weight loss
- First degree family member with IBD
- Anemia (HB \< -2 SD for age and gender)
- Increased marker of inflammation (ESR \>20 mm/hour or CRP \>10 mg/L)
- Extra-intestinal symptoms (erythema nodosum, arthritis, uveitis, thromboembolism, aphtous ulcera)
- We did not define any exclusion criteria.
Exclusion
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
355 Patients enrolled
Trial Details
Trial ID
NCT02197780
Start Date
September 1 2014
End Date
April 1 2017
Last Update
May 4 2017
Active Locations (19)
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1
Sint Vincentiusziekenhuis
Antwerp, Belgium
2
University Hospital Antwerpen
Antwerp, Belgium
3
University Hospital Gent
Ghent, Belgium
4
ZGT Almelo
Almelo, Netherlands, 7609 PP