Status:
COMPLETED
The CalproSmartNOR Study - a New Clinical Tool for Monitoring Patients With Inflammatory Bowel Disease
Lead Sponsor:
Helse Møre og Romsdal HF
Collaborating Sponsors:
Alesund Hospital
Calpro AS
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to prove that getting immediate calprotectin test results on the patients Smartphone (platforms such as Android or Iphone), will both stimulate patients with inflammatory bowe...
Detailed Description
There has been a shift in the therapeutic approach for inflammatory bowel disease (IBD) from symptom-tailored towards inflammation-targeted treatments. Mucosal healing, although not well-defined in pa...
Eligibility Criteria
Inclusion
- Ulcerative colitis and Crohns disease diagnosis that fulfil the international Copenhagen diagnostic criteria for inflammatory bowel diseases (IBD)
- Remission, mild or moderate disease activity defined as 6-point Mayo Score \<= 3 or Harvey Bradshaw index (HBI) \<= 16
- Written and oral consent about participation in the project
- In a mental and physical state in which every step of the procedure is understood and feasible
- Ability to obtain and prepare a fecal sample and to use the Smartphone application (platforms such as Android or Iphone)
Exclusion
- Severe disease activity defined as 6-point Mayo Score \> 3 or HBI \> 16
- Unable to read, understand or perform one or several steps of the procedure
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2020
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT03486158
Start Date
March 15 2018
End Date
March 27 2020
Last Update
April 13 2020
Active Locations (1)
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1
The Outpatient Clinic, Department of gastroenterology, Ålesund Hospital, Helse Møre og Romsdal HF
Ålesund, Norway