Resting Energy Expenditure in Pediatric Patients With Inflammatory Bowel Disease (REE-MICI)

NCT07670975 | Recruiting

• 1 other identifier: ASO.Ped.24.06
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Crohn Disease Colitis; Colitis, Ulcerative; Inflammatory Bowel Diseases

Keywords

Energy Metabolism; Calorimetry, Indirect; Malnutrition; Pediatric Obesity; Nutritional Status; Child; Disease Activity

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 2 months, and 9 months after diagnosis

Study Arms (1)

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.

Diagnostic Test: Indirect Calorimetry

Interventions

Indirect Calorimetry DIAGNOSTIC_TEST

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

Pediatric IBD Patients

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria: lead

Study Sites (1)

Pediatric Unit

Alessandria, Piedmont, 15121, Italy

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases; Malnutrition; Pediatric Obesity

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Obesity; Overweight; Overnutrition; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Clinical Trial Center (CTC)

CONTACT

0131206893; clinicaltrialcenter@ospedale.al.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: May 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)