Immune bowel disease Digestive System Irritable bowel syndrome
Conditions
Interventions
1. Investigation of the sensitivity and specificity of CalproQuest for stool Calprotectin levels = 50 µg/g feces and for positive IBD diagnosis:
Patients referred to the gastroenterolo
Sponsors
University Hospital of Zurich (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Are aged at least 18 years (part 1, 2) 2. Are referred to their gastroenterologist for any endoscopic examination (part 1) 3. Visit their GP because of on-going unspecific gastrointestinal symptoms (abdominal pain, bloating, stool irregularities, diarrhea) for at least two weeks (part 2) 4. Underwent no earlier diagnostic procedures (endoscopy) for the current episode (part 2)
Exclusion criteria
Exclusion criteria: 1. Are younger than 18 years (part 1, 2) 2. Have known further /other abdominal pathologies as e.g. cancer (part 1, 2) 3. Had previous abdominal surgeries (part 2) 4. Have been treated with steroids (topical and/or oral) and/or aminosalicylates within 30 days prior inclusion into this study (part 2) 5. Underwent endoscopic examination within 3 years prior screening (part 2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: 1.1. Sensitivity and specificity of CalproQuest for a positive Calprotectin test result 50 µg/g feces 1.2. Sensitivity and specificity of CalproQuest for a positive Calprotectin test result 50 µg/g feces and positive IBD-diagnosis. Part 2: 2.1 Feasibility of CalproQuest in daily primary care practice Timepoints: Part 1: Sensitivity and specificity (primary outcomes) will be measured 12 months after recruiting the last study centre (part 1: IBD-centre, part 2: GP) or earlier, when the target number of patients (part 1: 162, part 2: 80) has been achieved. Part 2: Feasibility of CalproQuest in daily primary care practice will be measured after the announcement of the Calprotectin test result, not exceeding 2 weeks after the consultation at the gastroenterologist or GP. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: Patient-reported diagnostic delay. Part 2: Patient acceptance of stool sampling. Timepoints: Part 1: Patient-reported diagnostic delay after the endoscopy exam, the whole procedure between first consultation and endoscopy will take at most 2 months. Part 2: Patient acceptance of stool sampling directly after fecal samples will be obtained at home (not exceeding 2 weeks after the consultation at the gastroenterologist or GP). | — |
Countries
Switzerland
Outcome results
None listed