Acceptability, Gastrointestinal Tolerance, Compliance and Palatability Study.
This study is for children aged 1 to 16 years who need extra nutritional drinks because they are malnourished due to an illness. We want to find out if a new type of nutritional drink, which contains special food blends, is well-liked by children and if it's easy for them to take. We'll be checking how it tastes, if children are happy to drink it regularly (compliance), and if it causes any tummy upsets or other side effects (gastrointestinal tolerance). The aim is to see if this new drink could be a good replacement for their current nutritional support, making it easier and more pleasant for children to get the nutrients they need.
At a glance
What is this study about?
This study is designed for children who need extra help with their nutrition. Sometimes, because of an illness, children don't get enough nutrients from their regular food, and they need special nutritional drinks. This study is testing a new ready-to-drink supplement that has a mix of different food ingredients.
The main goal is to see how well children accept this new drink. We want to know if it tastes good enough for them to drink it consistently, and if it's easy on their tummies. We will be looking at things like whether children are happy to finish the drink, if it causes any bloating or discomfort, and generally how they feel while taking it. This information is really important because if a nutritional drink tastes bad or causes tummy problems, children might not want to take it, which means they won't get the nutrition they need.
Ultimately, by finding out if this new nutritional drink is acceptable and well-tolerated, we hope to offer better options for children who rely on these supplements. Making nutritional support more pleasant and easier to manage can significantly improve a child's health and quality of life.
Key takeaways
- Tests a new nutritional drink for children aged 1-16 needing extra nutrients.
- Aims to see if the drink tastes good and is gentle on tummies.
- Could offer a better option for children needing nutritional support.
- Participation involves replacing current supplements with the new study drink.
- Your child's safety and comfort are the top priorities.
Who may be eligible?
This study is looking for children aged 1 to 16 years old. To be considered, your child must currently need and be taking one or more nutritional drinks because of an illness that causes them to be malnourished. It's important that your child is already stable and settled on their current nutritional support.
There are some reasons why a child might not be able to join the study. For example, if your child has difficulty swallowing safely, or if they have certain serious health conditions like advanced kidney or liver disease. Children with known food allergies to any of the ingredients in the new drink, or those with certain bowel problems like blockages, also can't take part. We also can't include children who are currently involved in another medical study or have been in one very recently.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Is your child aged between 1 and 16 years old?
- Does your child currently need and use nutritional drinks due to an illness?
- Is your child generally stable and well on their current nutritional support?
- Does your child NOT have severe kidney or liver disease, or known food allergies to the ingredients in the new drink?
- Can you give informed, written permission for your child to join the study?
What does participation involve?
If your child takes part in this study, the main activity will be replacing their current nutritional drink with the new study drink. You won't have to visit a clinic or hospital more often than you would for their usual care. Throughout the study, we will regularly check in to see how your child is doing. We'll ask about how they like the taste of the drink, if they're drinking it easily, and if they're experiencing any tummy problems like discomfort or sickness. The doctor will also assess your child's overall health during the study. We expect the study to last for a set period, which your study doctor will explain in detail, and it will involve replacing their current nutritional supplement with the study product for that duration.
Potential risks and benefits
Locations (1)
- DieteticsVerified postcodeNottingham, United Kingdom· Recruiting
Common questions
What is malnourishment?
Malnourishment means not getting enough of the right nutrients, which can happen if an illness affects how a child eats or absorbs food.
What is an 'oral nutritional supplement'?
It's a special drink that provides extra nutrients, like calories, protein, and vitamins, that a child might not be getting from their usual diet.
Will my child have to stop their regular food?
No, your child will continue their normal diet while replacing their current nutritional supplement with the new study drink.
What does 'gastrointestinal tolerance' mean?
It means how well the drink is accepted by the stomach and gut, without causing problems like stomach ache, bloating, sickness, or diarrhoea.
How long will the study last?
The study doctor will tell you the exact duration, but it involves replacing your child's current nutritional drink with the new one for a set period.
How to find out more
Sharan Saduera, BSc (Hons) Dietetics
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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