Crohn DiseaseTHERMO-CROHNNCT05710276
Assessment of Intestinal Inflammation by Infrared Thermography in Pediatric Crohn Disease
A study testing abdominal infrared radiation in people with Crohn Disease and Infrared Thermography, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Crohn Disease, Infrared Thermography, Child
- What is being tested?
- abdominal infrared radiation
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jun 2023to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Recent abdominal surgery
- Other Inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- abdominal infrared radiation
- Keywords
- Crohn Disease, Infrared thermography, Faecal Calprotectin, PCDAI, Child
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal infrared radiationOther
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start9 Jun 2023
- Primary completion28 Jul 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710276
- Sponsor's protocol ID
- PI2022_843_0001
- Acronym
- THERMO-CROHN
- Status last verified
- Jun 2026
- First submitted
- 24 Jan 2023
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Intestinal Inflammation by Infrared Thermography in Pediatric Crohn Disease
- ClinicalTrials.gov ID
- NCT05710276
- Acronym / sponsor ID
- THERMO-CROHN / PI2022_843_0001
- Conditions
- Crohn Disease, Infrared Thermography, Child
- Keywords
- Crohn Disease, Infrared thermography, Faecal Calprotectin, PCDAI, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Recent abdominal surgery
- Other Inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abdominal infrared radiationIn 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). | Other | – |
Primary outcome
correlation between the quantification of abdominal infrared radiation and faecal calprotectin concentration
Time frame: one year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing abdominal infrared radiation in people with Crohn Disease and Infrared Thermography, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between the quantification of abdominal infrared radiation and faecal calprotectin concentration (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.