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

NCT06723418 | Recruiting

• 1 other identifier: PIBD-NUTS
• Study Type: observational
• Target: 2,000
• Locations: 6 countries
• Sites: 8

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).

Conditions

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

Keywords

Ulcerative colitis; Crohns disease

Outcome Measures

Primary Outcomes (1)

• the performance of an existing nutritional screening tool (PYMS) in paediatric IBD patients at different international settings.

  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.

  1 year

Study Arms (1)

Pediatric patients with Inflammatory Bowel Disease (Crohns disease & ulcerative colitis)

Other: Malnutriton Screening Tool (PYMS)

Interventions

Malnutriton Screening Tool (PYMS) OTHER

In a pilot implementation study, PYMS will be used on children with IBD attending the outpatient and inpatient hospital clinics

Pediatric patients with Inflammatory Bowel Disease (Crohns disease & ulcerative colitis)

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All IBD (Crohns disease \& ulcerative colitis) patients (4-18 years) either admitted to hospital, or visiting their gastroenterologist's outpatient clinic for routine visits are eligible.

You may qualify if:

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

You may not qualify if:

• Pediatric patients with IBDU

Sponsors & Collaborators

• University of Glasgow: lead

Study Sites (8)

Salzburg University Hospital

Salzburg, Austria

RECRUITING

Children's Hospital Zagreb

Zagreb, Croatia

RECRUITING

University of Giessen

Giessen, Germany

RECRUITING

Erasmus MC university medical centre

Rotterdam, Netherlands

RECRUITING

The Children's Memorial Health Institute

Warsaw, Poland

RECRUITING

University Hospital Bristol and Weston

Bristol, United Kingdom

RECRUITING

Royal Hospital for Children and Young People

Edinburgh, United Kingdom

RECRUITING

Great Ormond Street Hospital

London, United Kingdom

RECRUITING

Related Publications (5)

• Gerasimidis K, Keane O, Macleod I, Flynn DM, Wright CM. A four-stage evaluation of the Paediatric Yorkhill Malnutrition Score in a tertiary paediatric hospital and a district general hospital. Br J Nutr. 2010 Sep;104(5):751-6. doi: 10.1017/S0007114510001121. Epub 2010 Apr 19.

  PMID: 20398432 BACKGROUND

• Gerasimidis K, Macleod I, Maclean A, Buchanan E, McGrogan P, Swinbank I, McAuley M, Wright CM, Flynn DM. Performance of the novel Paediatric Yorkhill Malnutrition Score (PYMS) in hospital practice. Clin Nutr. 2011 Aug;30(4):430-5. doi: 10.1016/j.clnu.2011.01.015. Epub 2011 Mar 9.

  PMID: 21388725 BACKGROUND

• Ng SC, Shi HY, Hamidi N, Underwood FE, Tang W, Benchimol EI, Panaccione R, Ghosh S, Wu JCY, Chan FKL, Sung JJY, Kaplan GG. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2017 Dec 23;390(10114):2769-2778. doi: 10.1016/S0140-6736(17)32448-0. Epub 2017 Oct 16.

  PMID: 29050646 BACKGROUND

• Hulst JM, Huysentruyt K, Gerasimidis K, Shamir R, Koletzko B, Chourdakis M, Fewtrell M, Joosten KF; Special Interest Group Clinical Malnutrition of ESPGHAN. A Practical Approach to Identifying Pediatric Disease-Associated Undernutrition: A Position Statement from the ESPGHAN Special Interest Group on Clinical Malnutrition. J Pediatr Gastroenterol Nutr. 2022 May 1;74(5):693-705. doi: 10.1097/MPG.0000000000003437. Epub 2022 Mar 3.

  PMID: 35258497 BACKGROUND

• Gerasimidis K, McGrogan P, Edwards CA. The aetiology and impact of malnutrition in paediatric inflammatory bowel disease. J Hum Nutr Diet. 2011 Aug;24(4):313-26. doi: 10.1111/j.1365-277X.2011.01171.x. Epub 2011 May 13.

  PMID: 21564345 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Central Study Contacts

Konstantinos Gerasimidis

CONTACT

0044 141 201 8689; konstantinos.gerasimidis@glasgow.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Nutrition

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 9, 2024
• Study Start: June 15, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); PL (1); DE (1); GB (3); AU (1); CR (1)