The CalproSmartNOR Study - a New Clinical Tool for Monitoring Patients With Inflammatory Bowel Disease
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ClinicalTrials.gov Identifier: NCT03486158 |
Recruitment Status :
Recruiting
First Posted : April 3, 2018
Last Update Posted : January 4, 2019
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Condition or disease | Intervention/treatment | Phase |
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Inflammatory Bowel Diseases | Device: CalproSmart™ system | Not Applicable |
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 past literature, is an objective marker of improvement as well as of favorable prognosis, not only in trials but also in routine clinical practice. However, utilization of frequent endoscopic procedures to assess mucosal healing would be a burden to patients and the stretched endoscopic services in the national health services. A non-invasive marker would give the opportunity to patients and physicians to titrate treatment to inflammatory activity with the aspiration to change the course of the disease.
Calprotectin (FCALP) is a calcium-binding protein abundant in the cytoplasm of neutrophils and macrophages that can be measured in feces reliably. Samples can be transported or stored at room temperature for at least 3 days. FCALP correlates well with histological and endoscopic disease activity in ulcerative colitis and radiology in Crohn's disease.
More importantly calprotectin predicts clinical relapse, outperforming other common non-invasive markers of inflammation (CRP, ESR), and it may also outperform endoscopy in predicting short and long term relapse.
Patients are currently required to provide a stool sample in a universal (non-specialized) container, which usually is processed in a central laboratory. The container is a small plastic cylinder secured with a screw top which has a longitudinal scoop attached to its inner surface. In order to collect the sample, the patients usually put some toilet paper in the toilet and after defecating use the scoop to collect the fecal sample. Then the container is brought to hospital in person and is processed by the laboratory staff. This is a laborious process, as a certain quantity of fecal material has to be manually extracted from each individual sample using a separate kit prior to the measurement, which is performed using an ELISA kit.
In relation to eHealth telemedicine's increasing importance as an aid to therapeutic approaches for IBD patients, the need for an accurate and user-friendly home test for measuring fecal calprotectin concentration has emerged. New technology has improved the collection device, and simplified the collection process by providing a paper sampler device placed over the toilet bowel, making the sampling both easier and cleaner. A preferred system should easily been able to convert the sample into an extract, measure the calprotectin concentration with a rapid-test read by a smartphone app, to produce an instant result for the patient at home which also concomitantly and securely should be sent via a portal to the treating clinician.
The CalproSmart™ system is a Home test kit for measurement of calprotectin in fecal samples, and a new clinical tool for monitoring patients with inflammatory bowel disease. The system consists of five components and a Smartphone- application; A) A sampler and nitrile gloves for collecting stool samples B) A prefilled extraction device to collect stool sample C) A lateral-flow rapid test D) A support frame with a design that enables measurement of calprotectin level of rapid test through a specially developed Smartphone application.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Optimalization of Disease Control and Quality of Life in Inflammatory Bowel Disease Using e-Health Measurements Via a Smart Phone Application; CalproSmart |
Actual Study Start Date : | March 15, 2018 |
Estimated Primary Completion Date : | February 2020 |
Estimated Study Completion Date : | February 2020 |
Arm | Intervention/treatment |
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Experimental: CalproSmart application
In addition to regular outpatient clinic visits and a routine CalproSmart test every 3 months, patients are instructed to obtain fecal samples if they experience symptoms suspect of recurrent IBD and to perform home analysis with CalproSmart™ system test kit
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Device: CalproSmart™ system
Home test kit for measurement of calprotectin in fecal samples. A new clinical tool for monitoring patients with inflammatory bowel disease, enabling measurement of calprotectin level of rapid test through a specially developed Smartphone application |
No Intervention: Standard follow-up
in addition to regular outpatient clinic visits and a routine calprotectin test in the same week as the visit date, patients bring home an F-calpro tube and envelope and are instructed to obtain fecal samples and send these to local lab if they experience symptoms suspect of recurrent IBD
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- remission rate [ Time Frame: 1 year ]
- time to disease flare for patients in remission at baseline visit [ Time Frame: 1 year ]
- time to remission for patients with mild to moderate disease activity in the course of the study [ Time Frame: 1 year ]
- Quality of life [ Time Frame: 1 year ]assessed by IBD-Q questionnaire (Norwegian version)
- number of hospitalizations [ Time Frame: 1 year ]
- number of outpatient clinic contacts [ Time Frame: 1 year ]
- work presenteeism/absenteeism [ Time Frame: 1 year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486158
Contact: Dag Arne Lihaug Hoff, md phd | + 47 70 10 50 00 | dag.hoff@helse-mr.no |
Norway | |
The Outpatient Clinic, Department of gastroenterology, Ålesund Hospital, Helse Møre og Romsdal HF | Recruiting |
Ålesund, Norway | |
Contact: Ingrid Prytz Berset, md + 47 70 10 50 00 ingrid.prytz.berset@helse-mr.no |
Study Director: | Dag Arne Lihaug Hoff, md phd | Helse Møre & Romsdal HF, Ålesund Hospital |
Responsible Party: | Helse Møre og Romsdal HF |
ClinicalTrials.gov Identifier: | NCT03486158 History of Changes |
Other Study ID Numbers: |
2017/1792 |
First Posted: | April 3, 2018 Key Record Dates |
Last Update Posted: | January 4, 2019 |
Last Verified: | January 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | ??????????????? |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Helse Møre og Romsdal HF:
Leukocyte L1 Antigen Complex Feces Cell Phone Biomarkers |
Recurrence Prognosis Clinical Chemistry Tests |
Additional relevant MeSH terms:
Intestinal Diseases Inflammatory Bowel Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis |