Resting Energy Expenditure in Pediatric Patients With Inflammatory Bowel Disease (REE-MICI)
Recruiting · NCT07670975 · Observational (researchers observe without assigning treatment) · Lead sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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
Where it is running
2 locations listed.
- Pediatric Unit - Alessandria, Piedmont, Italy
- Pediatric Unit - Alessandria, Piedmont, Italy