Crohn Disease Clinical Trial
— THERMO-CROHNOfficial title:
Assessment of Intestinal Inflammation by Infrared Thermography in Pediatric Crohn Disease
The assessment of digestive inflammation and disease activity in paediatrics Crohn's disease (CD) is currently based on anamnestic, clinical and paraclinical elements such as the paediatric CD activity index (wPCDAI) , faecal calprotectin measuring or digestive endoscopy. Infrared thermal imaging is based on capturing electromagnetic waves, on a specific Wavelength, emitted by the human body surface and representing local thermic-metabolic activity. It concern metabolic activity in digestive inflammations. Infrared imaging is a non-invasive, contactless, stressless technique that assess the variations in skin surface temperature of the patient's entire abdomen or more targeted areas in a single photography. This technique would be useful for determination of Crohn's disease activity, inflammation's degree and partial mapping of inflammatory lesions. In a specific room with a patient lying, the investigators will determine the abdominal infrared radiation with a FLIR® thermal camera. This will be correlated with the measurement of the faecal calprotectin concentration and the composite CD activity index wPCDAI. All measurements will be performed during the standard follow-up of Crohn disease. No additional follow will be necessary.
Status | Recruiting |
Enrollment | 43 |
Est. completion date | January 2024 |
Est. primary completion date | January 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 17 Years |
Eligibility | Inclusion Criteria: - Patients diagnosed with CD according to the Porto criteria [6] - Aged from 4 years to 17 years-old - Follow-up at the Amiens Picardie University Hospital (CHU Amiens Picardie) - Child's affirmative agreement and assent and permission of their parents to participate in research Exclusion Criteria: - Recent abdominal surgery - Other Inflammatory bowel disease |
Country | Name | City | State |
---|---|---|---|
France | CHU Amiens | Amiens |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire, Amiens |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | correlation between the quantification of abdominal infrared radiation and faecal calprotectin concentration | correlation between the quantification of abdominal infrared radiation determined by the FLIR® thermal camera and quantified by the spectral analysis of the thermal signal (in degrees Celsius) and the determination of faecal calprotectin concentration (µg/g of faeces). This concentration will be determined by ELISA method at Biochemistry in Amiens Picardie Faculty hospital. | one year |
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