Crohn Disease ColitisREE-MICINCT07670975
Resting Energy Expenditure in Pediatric Patients With Inflammatory Bowel Disease (REE-MICI)
An observational study of Crohn Disease Colitis and Colitis, Ulcerative, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
Trial summary
This multicenter prospective observational non-pharmacological study aims to evaluate resting energy expenditure (REE) in pediatric patients affected by inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Crohn Disease Colitis, Colitis, Ulcerative, Inflammatory Bowel Diseases
- What is being tested?
- Indirect Calorimetry
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2025to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients aged 6 to 17 years with newly diagnosed inflammatory bowel disease, including Crohn disease and ulcerative colitis, recruited from participating Italian centers with availability of indirect calorimetry assessment.
Who may be able to join
- Pediatric patients aged 6 to 17 years
- New diagnosis of inflammatory bowel disease, including Crohn disease or ulcerative colitis, according to ECCO/ESPGHAN criteria
- Written informed consent signed by parents or legal guardians
Who cannot join
- Intestinal surgery within 6 weeks before the first evaluation
- Parenteral or enteral nutrition within 6 weeks before the first evaluation
- Eating disorders or other chronic diseases associated with possible malabsorption
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Pediatric Unit
Alessandria, Piedmont, 15121
Clinical Trial Center, 0131206893, clinicaltrialcenter@ospedale.al.it
About this study
Official title: Measurement of Basal Metabolism in Patients With Crohn's Disease and Ulcerative Colitis and Correlation With Disease Activity.
This multicenter prospective observational non-pharmacological study aims to evaluate resting energy expenditure (REE) in pediatric patients affected by inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. REE will be measured using indirect calorimetry and estimated using predictive equations. The study also aims to investigate the relationship between REE, disease activity, and dietary or pharmacological treatments. Clinical, laboratory, anthropometric, nutritional, and disease activity data will be collected during routine clinical follow-up at diagnosis, after induction therapy, and during follow-up visits.
Read the detailed description
Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are associated with an increased risk of malnutrition and growth impairment in pediatric patients. Chronic inflammation, reduced oral intake, malabsorption, and increased metabolic demand may contribute to altered nutritional status and increased resting energy expenditure (REE).
Resting energy expenditure represents the amount of energy required to maintain basic physiological functions at rest and accounts for most daily energy consumption. Accurate evaluation of REE is important to optimize nutritional support and avoid underfeeding or overfeeding in children with IBD.
This study is a national multicenter prospective observational no-profit study involving pediatric patients aged 6 to 17 years with a new diagnosis of IBD according to ECCO/ESPGHAN criteria. Approximately 50 patients are expected to be enrolled.
REE will be measured using indirect calorimetry and compared with predictive equations. Clinical and laboratory parameters routinely collected during standard clinical care will also be evaluated, including disease activity indices (PUCAI/PCDAI), anthropometric measurements, biochemical parameters, fecal calprotectin, dietary intake, physical activity questionnaires, and endoscopic scores.
Data will be collected at diagnosis, after induction therapy, and during follow-up visits. The study aims to identify possible correlations between REE, disease activity, and dietary or pharmacological treatments in pediatric patients with IBD.
- Being tested
- Indirect Calorimetry
- Keywords
- Energy Metabolism, Calorimetry, Indirect, Malnutrition, Pediatric Obesity, Nutritional Status, Child, Disease Activity
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases, Malnutrition, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect CalorimetryDiagnostic test
Also called Resting Energy Expenditure Assessment, REE Measurement
Resting energy expenditure (REE) assessment performed using indirect calorimetry in pediatric patients with inflammatory bowel disease during routine clinical follow-up. Measurements are obtained under resting conditions after fasting and are used to evaluate energy metabolism and its relationship with disease activity and treatments.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric IBD Patients | Pediatric patients aged 6 to 17 years with a new diagnosis of inflammatory bowel disease, including Crohn disease and ulcerative colitis, enrolled in this prospective multicenter observational study. Participants undergo resting energy expenditure assessment by indirect calorimetry together with routine clinical, laboratory, anthropometric, nutritional, and disease activity evaluations during follow-up. Receives: Diagnostic Test: Indirect Calorimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting Energy Expenditure measured by indirect calorimetry
Assessment of resting energy expenditure (REE) in pediatric patients with inflammatory bowel disease using indirect calorimetry and comparison with predictive equations.
Measured: Baseline, 2 months, and 9 months after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 May 2025
- Primary completionMar 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease ColitisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670975
- Sponsor's protocol ID
- ASO.Ped.24.06
- Acronym
- REE-MICI
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- 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 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Basal Metabolism in Patients With Crohn's Disease and Ulcerative Colitis and Correlation With Disease Activity.
- ClinicalTrials.gov ID
- NCT07670975
- Acronym / sponsor ID
- REE-MICI / ASO.Ped.24.06
- Keywords
- Energy Metabolism, Calorimetry, Indirect, Malnutrition, Pediatric Obesity, Nutritional Status, Child, Disease Activity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 26 Jun 2026 (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.
This multicenter prospective observational non-pharmacological study aims to evaluate resting energy expenditure (REE) in pediatric patients affected by inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. REE will be measured using indirect calorimetry and estimated using predictive equations. The study also aims to investigate the relationship between REE, disease activity, and dietary or pharmacological treatments. Clinical, laboratory, anthropometric, nutritional, and disease activity data will be collected during routine clinical follow-up at diagnosis, after induction therapy, and during follow-up visits.
Detailed description
Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are associated with an increased risk of malnutrition and growth impairment in pediatric patients. Chronic inflammation, reduced oral intake, malabsorption, and increased metabolic demand may contribute to altered nutritional status and increased resting energy expenditure (REE).
Resting energy expenditure represents the amount of energy required to maintain basic physiological functions at rest and accounts for most daily energy consumption. Accurate evaluation of REE is important to optimize nutritional support and avoid underfeeding or overfeeding in children with IBD.
This study is a national multicenter prospective observational no-profit study involving pediatric patients aged 6 to 17 years with a new diagnosis of IBD according to ECCO/ESPGHAN criteria. Approximately 50 patients are expected to be enrolled.
REE will be measured using indirect calorimetry and compared with predictive equations. Clinical and laboratory parameters routinely collected during standard clinical care will also be evaluated, including disease activity indices (PUCAI/PCDAI), anthropometric measurements, biochemical parameters, fecal calprotectin, dietary intake, physical activity questionnaires, and endoscopic scores.
Data will be collected at diagnosis, after induction therapy, and during follow-up visits. The study aims to identify possible correlations between REE, disease activity, and dietary or pharmacological treatments in pediatric patients with IBD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric IBD Patients | – | Diagnostic Test: Indirect CalorimetryPediatric patients aged 6 to 17 years with a new diagnosis of inflammatory bowel disease, including Crohn disease and ulcerative colitis, enrolled in this prospective multicenter observational study. Participants undergo resting energy expenditure assessment by indirect calorimetry together with routine clinical, laboratory, anthropometric, nutritional, and disease activity evaluations during follow-up. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients aged 6 to 17 years with newly diagnosed inflammatory bowel disease, including Crohn disease and ulcerative colitis, recruited from participating Italian centers with availability of indirect calorimetry assessment.
Key inclusion criteria (3 listed)
- Pediatric patients aged 6 to 17 years
- New diagnosis of inflammatory bowel disease, including Crohn disease or ulcerative colitis, according to ECCO/ESPGHAN criteria
- Written informed consent signed by parents or legal guardians
Key exclusion criteria (3 listed)
- Intestinal surgery within 6 weeks before the first evaluation
- Parenteral or enteral nutrition within 6 weeks before the first evaluation
- Eating disorders or other chronic diseases associated with possible malabsorption
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 |
|---|---|---|
| Indirect CalorimetryAlso: Resting Energy Expenditure Assessment, REE MeasurementResting energy expenditure (REE) assessment performed using indirect calorimetry in pediatric patients with inflammatory bowel disease during routine clinical follow-up. Measurements are obtained under resting conditions after fasting and are used to evaluate energy metabolism and its relationship with disease activity and treatments. | Diagnostic test | Pediatric IBD Patients |
Primary outcome
Resting Energy Expenditure measured by indirect calorimetry
Time frame: Baseline, 2 months, and 9 months after diagnosis
Assessment of resting energy expenditure (REE) in pediatric patients with inflammatory bowel disease using indirect calorimetry and comparison with predictive equations.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease Colitis and Colitis, Ulcerative, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 26 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Center (CTC) (0131206893, clinicaltrialcenter@ospedale.al.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting Energy Expenditure measured by indirect calorimetry (time frame: Baseline, 2 months, and 9 months after diagnosis). 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 26 Jun 2026.