Resting Energy Expenditure in Pediatric Patients With Inflammatory Bowel Disease (REE-MICI)
- Sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Study ID
- NCT07670975
- Status
- Recruiting
Conditions
- Colitis, Ulcerative
- Crohn Disease Colitis
- Inflammatory Bowel Diseases
Eligibility Criteria
- Sex
- ALL
- Age
- 6 Years - 17 Years
- Healthy Volunteers
- Not accepted
Interventions
- Indirect Calorimetry — DIAGNOSTIC_TESTResting 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 Details
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.
Key Dates
- First listed
- Jun 26, 2026
- Start date
- May 1, 2025
- Status verified
- Jun 2026
- Primary completion
- Mar 31, 2027
- Completion
- Nov 30, 2027
Study Design
- Enrollment
- 50 participants (estimated)
Arms
- Arm: Pediatric IBD PatientsPediatric 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.
Primary Outcome Measure
Resting Energy Expenditure measured by indirect calorimetry [ Time Frame: Baseline, 2 months, and 9 months after diagnosis ]
Central Contacts
- Clinical Trial Center (CTC)0131206893
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