Assessment of Intestinal Inflammation by Infrared Thermography in Pediatric Crohn Disease

Crohn Disease Clinical Trial

— THERMO-CROHN  

Official title:

Assessment of Intestinal Inflammation by Infrared Thermography in Pediatric Crohn Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05710276
• Other study ID #: PI2022_843_0001
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2023
• Est. completion date: January 2024

Study information

• Verified date: January 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: DJAMAL-DINE DJEDDI, Pr
• Phone: 03.22.08.76.32
• Email: djeddi.djamal-dine[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Child
• Crohn Disease
• Inflammation
• Infrared Thermography

Intervention

Other:
• abdominal infrared radiation
In a specific room (controlled temperature and humidity) with a patient lying on his back, we will determine the abdominal infrared radiation with a FLIR® thermal camera (without contact) and quantify the thermal signal by spectral analysis (in degrees Celsius).

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

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