An observational study in Crohn Disease Colitis, Colitis, Ulcerative and Inflammatory Bowel Diseases, sponsored by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria. Recruiting at 1 site in Italy. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria · Observational
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.
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.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 50 is below the median of 198 across 551 observational studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria is the lead sponsor of 37 studies on the registry; 13 are open to participants now.
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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.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Indirect Calorimetry
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.
Also known as: Resting Energy Expenditure Assessment, REE Measurement
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.
Time frame: Baseline, 2 months, and 9 months after diagnosis
Plan to share: No
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Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria