Development and Validation of a New Paediatric Inflammatory Bowel Disease NUTrition Risk Score (PIBD-NUTS)

Recruiting

• Conditions: Inflammatory Bowel Diseases (IBD); Crohns Disease; Ulcerative Colitis (UC)

• Registration Number: NCT06723418
• Lead Sponsor: University of Glasgow

Brief Summary

Children with inflammatory bowel disease (IBD) including both Crohn's disease (CD) and ulcerative colitis (UC) can be at high risk of developing malnutrition due to the nature of their condition. It is also believed that some children with IBD, in need of nutritional care, are not identified quickly by their healthcare professionals. This may negatively affect their nutrition, disease progression and general well-being. Hence, it has been proposed that nutritional screening tools or scores (NSTs) should be used to promptly identify children needing further dietetic review and input. Although there are a few NSTs for generic use in sick children at hospital admission, NSTs or scores to use for children with IBD are currently missing. In this study, we would like to test the performance of an existing tool that is routinely used for all sick children at hospital admission (The Paediatric Yorkhill Malnutrition Score or PYMS)(5) and test whether PYMS can detect children with IBD who are at risk of malnutrition. If PYMS doesn't work well, we will develop a specific tool for children with IBD (The Paediatric IBD Nutrition Score or PIBD-NUTS).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-15
• Status Verified: 2024-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-02
• Study First Posted: 2024-12-09
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Pediatric patients with either Crohn's disease or ulcerative colitis between the ages of (4-18 years)

Exclusion Criteria

• Pediatric patients with IBDU

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the performance of an existing nutritional screening tool (PYMS) in paediatric IBD patients at different international settings.	1 year	The primary outcome measure for our study is to evaluate the performance of an existing nutritional screening tool, the Paediatric Yorkhill Malnutrition Score (PYMS), specifically in pediatric IBD patients across various international settings. We aim to assess its diagnostic accuracy by examining sensitivity and specificity.

Trial Locations

Locations (8)

Salzburg University Hospital; 🇦🇹 Salzburg, Austria

Children's Hospital Zagreb; 🇭🇷 Zagreb, Croatia

University of Giessen; 🇩🇪 Giessen, Germany

Erasmus MC university medical centre; 🇳🇱 Rotterdam, Netherlands

University Hospital Bristol and Weston; 🇬🇧 Bristol, United Kingdom

Royal Hospital for Children and Young People; 🇬🇧 Edinburgh, United Kingdom

Great Ormond Street Hospital; 🇬🇧 London, United Kingdom

The Children's Memorial Health Institute; 🇵🇱 Warsaw, Poland