Status:
COMPLETED
IBDoc® Canadian User Performance Evaluation
Lead Sponsor:
Bühlmann Laboratories AG
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
12+ years
Phase:
NA
Brief Summary
The objective of the IBDoc® user performance evaluation is to demonstrate the ease-of-use of the IBDoc® calprotectin home test to allow patients with inflammatory bowel disease (IBD) to independently ...
Detailed Description
The patient will determine the calprotectin concentration in their own stool sample using the IBDoc® assay. For this, the patient will collect a stool sample in a standard collection tube at home. The...
Eligibility Criteria
Inclusion
- Patients \> 12 years
- IBD Outpatients from a tertiary gastroenterological health care center willing to participate.
- Patients diagnosed with Ulcerative Colitis (UC) or Crohn's disease (CD), according to classical criteria (laboratory testing and exclusion of other possible causes: complete blood count, comprehensive metabolic panel, serological markers e.g. antineutrophil cytoplasmic antibody (ANCA), inflammatory markers in blood and serum: erythrocyte sedimentation rate, C-reactive protein (CRP); fecal occult blood and fecal calprotectin assays; confirmation by endoscopy, histology of a biopsy)
- At least 30% patients should display active disease. This can be defined by a Harvey-Bradshaw index (HBI) \> 5 in CD and a clinical Mayo score \> 2 in UC
- Remaining patients in clinical remission or only mildly active disease defined by a HBI\<7 in CD and a clinical Mayo score \< 3 in UC with a stable medical treatment
- In case of a prescribed endoscopy, the observation period starts \>3 days after colonoscopy
- Stable care of a treating physician
- Signed informed consent
Exclusion
- Other known pathology or predisposition that may interfere with the ability to perform the measurement procedures or that may influence calprotectin levels such as acute diarrhea or chronic use of non-steroidal anti-inflammatory drugs
- Inability to understand the procedures
- Inability to psychologically handle potential test outcomes
Key Trial Info
Start Date :
May 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2017
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT03408249
Start Date
May 5 2017
End Date
August 22 2017
Last Update
January 24 2018
Active Locations (3)
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1
Division of Gastroenterology, Department of Medicine, Faculty of Medicine University of Alberta,
Edmonton, Alberta, Canada, T6G 2R7
2
GIRI (GI Research Institute)
Vancouver, British Columbia, Canada, V6Z 2K5
3
Hôtel-Dieu de Lévis,
Lévis, Quebec, Canada