Last reviewed · How we verify
NCT03408249
IBDoc® Canadian User Performance Evaluation
NA trial testing IBDoc calprotectin test in Inflammatory Bowel Diseases in 61 participants. Completed in 22 August 2017.
22 August 2017
Quick facts
| Lead sponsor | Bühlmann Laboratories AG |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 61 |
| Start date | 5 May 2017 |
| Primary completion | 22 August 2017 |
| Estimated completion | 22 August 2017 |
| Sites | 3 locations across Canada |
Drugs / interventions tested
- IBDoc calprotectin test
- questionnaire
Conditions studied
- Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
Sponsor
Bühlmann Laboratories AG
Who can join
12 and older, any sex, with Inflammatory Bowel Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 and correctly determine calprotectin concentration in their own stool sample. The study is based on Chapter 8 of the International Organization for Standardization (ISO) Standard, ISO 15197:2013 "In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus". The study is a prospective, multicenter study, not blinded for patients, and includes a total of 61 patients.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
IBDoc Canadian User Performance Evaluation.
Moore AC, Huang VW, Bourdages R, Fedorak RN, et al · · 2019 · cited 8× · PMID 30535387 · DOI 10.1093/ibd/izy357
Verify or expand the search:
- PubMed search for NCT03408249
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Inflammatory Bowel Diseases
Currently open trials in the same condition.
- NCT07520747 — A Database Study of Disease, Treatment Patterns and Healthcare Use in Children With Inflammatory Bowel Diseases in Korea · recruiting
- NCT07349472 — Pentoxifylline in Patients With Ulcerative Colitis · Phase 2 · recruiting
- NCT07033208 — Feasibility of a Wireless Thermal Capsule Endoscopy to Detect Gastrointestinal Thermal Variance · NA · recruiting
- NCT06842316 — Effects of Phytocannabinoids on Immune Response and Autophagy During Chronic Immune-mediated Inflammatory Diseases · recruiting
- NCT06453317 — Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis · Phase 2 · recruiting
Other Bühlmann Laboratories AG trials
Trials by the same sponsor.
- NCT04548778 — BÜHLMANN FPELA in the Diagnosis of Exocrine Pancreatic Insufficiency · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03408249 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bühlmann Laboratories AG
- Last refreshed: 24 January 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03408249.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing