RecruitingOBSERVATIONAL

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

Children with inflammatory bowel disease (IBD), which includes Crohn's disease and ulcerative colitis, can often struggle with getting enough nutrients. Sometimes, healthcare staff might not spot this quickly enough, which can affect a child's health and how their condition progresses. This study wants to find a better way to identify these children promptly. We're first testing an existing tool, the Paediatric Yorkhill Malnutrition Score (PYMS), which is used for all sick children. If PYMS doesn't work well for children with IBD, we will then develop a new, specific tool called the Paediatric IBD Nutrition Score (PIBD-NUTS). The goal is to make sure children with IBD receive the right dietary support when they need it most.

At a glance

Status

Recruiting

Sponsor

University of Glasgow

Enrolment target

2,000

Start

15 Jun 2024

Estimated completion

01 Dec 2026

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

What is this study about?

When children have inflammatory bowel disease (IBD), like Crohn's disease or ulcerative colitis, their bodies might not absorb nutrients properly, or their condition might make it hard to eat enough. This can lead to them not getting all the good food they need, which we call malnutrition. It's really important to spot this early so that children can get the right help and support from dietitians and other healthcare team members.

Currently, there isn't a specific way to quickly check for malnutrition in children with IBD. Doctors and nurses use tools to check other sick children, but we're not sure if these tools work well for IBD. This study wants to figure out the best way to identify children with IBD who are at risk of malnutrition.

The first step is to see if an existing tool, called the Paediatric Yorkhill Malnutrition Score (PYMS), can effectively find these children. Nurses often use PYMS when children first come into hospital. If PYMS isn't quite right for children with IBD, then the researchers will create a brand new tool. This new tool, called the Paediatric IBD Nutrition Score (PIBD-NUTS), would be designed specifically for children living with Crohn's disease or ulcerative colitis.

Key takeaways

The study aims to improve how malnutrition is identified in children with IBD.
It will test an existing tool (PYMS) or develop a new one (PIBD-NUTS).
Early identification helps children with IBD receive timely nutritional support.
Participation will use existing health information, no new treatments.
Eligible participants are children aged 4-18 with Crohn's disease or ulcerative colitis.

Who may be eligible?

This study is looking for children and young people between the ages of 4 and 18 years old. To be able to take part, they must have a confirmed diagnosis of either Crohn's disease or ulcerative colitis.

Children with a specific type of IBD called 'IBDU' (Inflammatory Bowel Disease Unclassified) will not be able to join this study. IBDU means that doctors haven't been able to say for sure if it's Crohn's disease or ulcerative colitis yet.

Quick self-check

Is your child aged between 4 and 18 years old?
Does your child have a confirmed diagnosis of Crohn's disease?
Does your child have a confirmed diagnosis of ulcerative colitis?
Does your child NOT have a diagnosis of IBDU (Inflammatory Bowel Disease Unclassified)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

The study aims to observe and collect information, rather than involve new treatments or procedures beyond what is typical for your child's care. If your child is suitable for the study, existing information about their health, such as their type of IBD and their nutritional status notes, would be used. The research team would assess how well the PYMS screening tool identifies children at risk of malnutrition during their routine hospital visits or admissions. If this tool doesn't work well, the researchers would then develop a new tool using information gathered from children with IBD. There are no extra hospital visits, specific assessments, new medications, or follow-up appointments solely for this study. The total duration of your child's involvement would depend on how long it takes to collect the necessary data to test PYMS or develop the new tool.

Potential risks and benefits

Taking part in this study primarily involves using information already collected during your child's routine care; there are no new medical procedures or treatments. Therefore, there are no direct physical risks to your child from participating. The main benefit is that this research could lead to a better system for spotting malnutrition early in children with IBD, ensuring they get the most appropriate and timely nutritional support. You are always free to change your mind about your child taking part at any point, without needing to give a reason, and this will not affect their medical care.

Locations (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

Common questions

What is malnutrition?

Malnutrition means not getting enough of the right nutrients, which can make you feel tired, lose weight, and affect your growth and ability to fight off illness.

What are IBD, Crohn's disease, and ulcerative colitis?

These are long-term conditions where parts of the gut become inflamed (sore and swollen). Crohn's can affect any part of the gut, while ulcerative colitis mainly affects the large bowel.

What is a 'screening tool'?

A screening tool is a simple way for healthcare professionals to quickly check if a child might be at risk of a problem, like malnutrition, so they can get help if needed.

Will taking part in this study change my child's medical care?

No, this study will not change your child's usual medical care. It aims to improve how malnutrition is identified, which could benefit future patients.

Is my child guaranteed to get better if they are identified with malnutrition?

Identifying malnutrition early means your child can receive expert advice and support from dietitians and other healthcare professionals to help manage it, which is often very beneficial.

How to find out more

Konstantinos Gerasimidis

konstantinos.gerasimidis@glasgow.ac.uk 0044 141 201 8689 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.