Assessment of Intestinal Inflammation by Infrared Thermography in Pediatric Crohn Disease

NCT05710276 | Unknown

• 1 other identifier: PI2022_843_0001
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn Disease; Infrared Thermography; Child

Keywords

Crohn Disease; Infrared thermography; Faecal Calprotectin; PCDAI; Child

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

abdominal infrared radiation OTHER

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).

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Recent abdominal surgery
• Other Inflammatory bowel disease

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

DJAMAL-DINE DJEDDI, Pr

CONTACT

03.22.08.76.32; djeddi.djamal-dine@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 2, 2023
• Study Start: January 24, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: February 6, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)