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RecruitingNAINTERVENTIONAL

Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends

This study is testing a special liquid food that’s given through a feeding tube directly into the stomach. It’s designed for people who need help getting enough nutrients, especially those with conditions like Cerebral Palsy or cancer. We want to find out how well people’s bodies handle this liquid food and if they find it easy to use over a 28-day period. Up to 50 children and adults will take part. The aim is to check how their tummy responds and how much of the food they take in. At the end, participants will share their opinions on the food. This will help doctors and dietitians understand if this liquid food could be a good option for others.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Société des Produits Nestlé (SPN)
Enrolment target
50
Start
10 Dec 2025
Estimated completion
11 Nov 2026

What is this study about?

This study is all about a special liquid food, sometimes called a 'tube feed', which is given through a tube directly into the stomach. This type of feeding is often used when people can't eat enough by mouth or have conditions that make it hard to absorb nutrients from regular food. The special liquid food being tested is designed to help people who are not getting enough nutrition, perhaps because of conditions like Cerebral Palsy or cancer, and many other situations where people need extra help to get the right nutrients into their body.

The main goal of the study is to see how well people's bodies cope with this liquid food. We call this 'gastrointestinal tolerance', which simply means how well your tummy and bowel handle it – for example, if it causes discomfort, bloating, or other tummy upsets. We also want to see if people find it acceptable and if they can stick to taking it as planned. This information is really important because if a liquid food is well-tolerated and liked, it’s more likely to help people get the nutrition they need to stay healthy.

Over 28 days, up to 50 children and adults will take part. During this time, the study team will keep track of how much of the liquid food you take and how your tummy responds. At the very end, you'll be asked to fill out a short questionnaire to share your thoughts on the special liquid food. Your feedback will help us understand if this liquid food could be a good option for other patients in the future.

Key takeaways

  • This study tests a new liquid food given through a stomach feeding tube.
  • It aims to see if the food is well-tolerated and liked by people with certain health conditions.
  • Participants will be children and adults who are already using a gastrostomy tube.
  • The study lasts 28 days, checking tummy responses and overall satisfaction.
  • Your input could help improve tube feeding options for others.
  • You can leave the study at any time without affecting your medical care.

Who may be eligible?

To join this study, participants need to be between 1 and 15 years old for children, or 15 years and older for adults. You must already be getting some of your food through a tube into your stomach (a 'gastrostomy tube') and your current feeding routine should be stable and settled. This means you’re not having major problems with your usual tube feed or a homemade blended diet.

There are also some reasons why you might not be able to join. For example, if you are under one year old, or if you use a feeding tube that goes through your nose (nasogastric) or further down into your gut (jejunal), you wouldn't be able to participate. Also, if you have severe kidney or liver problems, have certain serious bowel conditions, or are undergoing other interventional studies, this study might not be right for you. It's also important that you don't have any known allergies to the ingredients in the special liquid food being tested.

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.

  1. Are you between 1 and 15 years old (for children) or 15 years or older (for adults)?
  2. Do you get your tube feed directly into your stomach (a gastrostomy tube)?
  3. Are you currently stable and getting on well with your usual tube feeding?
  4. Do you feel you can keep to the study plan for 28 days?
  5. Are you able to give written consent, or can your caregiver give it for you?
Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last for 28 days. During this time, you will continue with your usual tube feeding, but with an added amount of the special liquid food being tested. For the first 7 days, the study team will closely monitor how your tummy handles the new liquid food. Over the full 28 days, they will also keep track of how much of the new liquid food you are taking. At the very end of the 28 days, you will be asked to fill out a questionnaire to share your experiences and say how satisfied you are with the liquid food. There are no extra hospital visits planned just for this study, as the information will be collected during your usual care.

Potential risks and benefits

Taking part in this study could help us learn more about special liquid foods, which might lead to better options for people who need tube feeding. You might find the new liquid food works well for you, potentially improving your nutrition. However, like with any new food, there's a small chance you might experience some mild tummy discomfort, such as bloating or gas. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Queen Medical Hospital Nutrition and Dietetics
    Verified postcode
    Nottingham, United Kingdom· Not yet recruiting
  • Dietetic Team 1st floor Kings Court 1, Charles Hastings Way,
    Verified postcode
    Worcester, United Kingdom· Recruiting

Common questions

What is a 'bolus tube feed'?

It's a way of giving liquid food through a feeding tube quickly, usually over 15-20 minutes, rather than slowly over many hours.

What is a 'gastrostomy tube'?

It's a feeding tube that goes directly into your stomach through a small opening made in the tummy area.

Will I stop my usual food if I join?

No, you will continue your usual tube feed or blended diet alongside the new liquid food for the study.

How long will the study last for me?

Your involvement in the study will last for 28 days.

What if I don't like the new food or it upsets my tummy?

You can stop taking part in the study at any time if you feel unwell or decide it's not for you.

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?

Register your interest

Share your details and the research team for "Acceptability and Tolerance Study of Bolus Tube Feed With Fo…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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