Assessment of Intestinal Inflammation by Infrared Thermography in Pediatric Crohn Disease

NCT ID: NCT05710276

Last Updated: 2023-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-24

Study Completion Date

2024-01-31

Brief Summary

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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 FLIRĀ® 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.

Detailed Description

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Conditions

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Crohn Disease Infrared Thermography Child

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Interventions

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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 FLIRĀ® thermal camera (without contact) and quantify the thermal signal by spectral analysis (in degrees Celsius).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens

Amiens, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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DJAMAL-DINE DJEDDI, Pr

Role: CONTACT

03.22.08.76.32

Facility Contacts

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Djamal-Dine Djeddi, MD

Role: primary

(33)322087632

Djamal-Dine Djeddi

Role: backup

(33)322087632

Other Identifiers

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PI2022_843_0001

Identifier Type: -

Identifier Source: org_study_id

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