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

22. juni 2026 opdateret af: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

50

Kontakter og lokationer

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Studiekontakt

Studiesteder

Deltagelseskriterier

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Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Diagnostisk 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.
Andre navne:
  • Resting Energy Expenditure Assessment
  • REE Measurement

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Resting Energy Expenditure measured by indirect calorimetry
Tidsramme: 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.
Baseline, 2 months, and 9 months after diagnosis

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2025

Primær færdiggørelse (Anslået)

1. marts 2027

Studieafslutning (Anslået)

1. november 2027

Datoer for studieregistrering

Først indsendt

22. juni 2026

Først indsendt, der opfyldte QC-kriterier

22. juni 2026

Først opslået (Faktiske)

26. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ASO.Ped.24.06

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Inflammatoriske tarmsygdomme

Kliniske forsøg med Indirect Calorimetry

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