RecruitingNAINTERVENTIONAL

Elemental 028 Extra Case Studies

This study is about a new and improved version of a special liquid diet called Elemental 028 Extra. This diet is a complete food source for people, including children, who have very serious digestive problems or severe allergies. It's designed to give them all the nutrients they need when their gut can't properly digest regular food. We're looking at how 30 patients (adults and children) find this new formula – whether they like the taste, if it's easy to use, and if it helps their tummy feel better or causes any discomfort. The study will last for 29 days and is being done in several clinics across the UK to make sure the new formula meets important health standards.

At a glance

Status

Recruiting

Phase

Sponsor

Nutricia UK Ltd

Enrolment target

Start

01 May 2025

Estimated completion

01 Feb 2027

Gastrointestinal Disease Inflammatory Bowel Disease (IBD)Short Bowel Malabsorption Allergies Neurodegenerative Disorders

What is this study about?

You might be reading this if you or someone you care for has serious digestive issues or severe allergies, where regular food is hard to digest. This study is all about a special type of liquid food called an 'elemental diet'. Think of it as food where all the difficult-to-digest parts, like proteins, have already been broken down into very simple forms your body can absorb easily. This particular one, Elemental 028 Extra, is a complete food, meaning it gives you all the energy, protein, vitamins, and minerals you need.

Doctors sometimes recommend elemental diets when someone's gut is very unwell, perhaps due to conditions like Inflammatory Bowel Disease (IBD), Short Bowel Syndrome (where part of the intestine is missing or doesn't work well), or certain severe allergies. This special diet helps ensure the body gets the nutrients it needs without putting a strain on the digestive system or triggering allergic reactions. It's a bit like giving your gut a rest while still feeding your body completely.

The makers of Elemental 028 Extra have updated their formula to include more energy, protein, and other important nutrients, aiming to make it even better for patients. This study wants to find out if this new version is well-liked by patients, whether it's easy to use as part of their daily life, and importantly, if it's kind to their stomach and doesn't cause any new tummy problems. Your feedback, if you join, would be really valuable in helping future patients.

Key takeaways

It's about a new version of a special liquid diet called Elemental 028 Extra.
Aimed at people aged 3+ with severe gut problems or allergies who need this diet.
Looks at how people like it, if they can use it, and if it causes tummy problems.
The study lasts 29 days.
Your feedback helps improve this diet for future patients.

Who may be eligible?

To join this study, people must be at least 3 years old. You'd need to be someone who already uses or needs to use an elemental liquid diet to get a good portion (at least 30%) of your daily food intake. We would also need to get your clear agreement to take part, either from you directly, or from a parent or caregiver if you're a child.

There are also some reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, or if you already receive all your nutrition through a tube directly into your veins (called parenteral nutrition). People with serious liver or kidney problems, or those who have taken part in another study in the past month, also wouldn't be able to join. Lastly, if the study team feels you or your caregiver might find it difficult to follow the study instructions, you might not be eligible.

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.

Are you or the person you care for at least 3 years old?
Do you (or they) currently need an elemental liquid diet for a significant part of your nutrition?
Are you (or they) NOT pregnant or breastfeeding?
Do you (or they) NOT have severe liver or kidney problems?
Have you (or they) NOT taken part in another clinical study within the last month?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last for a total of 29 days. It starts with one day for baseline checks, where we gather some initial information about you. Then, for the next 28 days, you would use the new Elemental 028 Extra formula as directed by the study team. You would be given either the powder or liquid version of the formula. During this time, the study team will check in with you to see how you are getting on with the new diet. They'll ask about how you like it, if you're able to use it regularly, and if you experience any tummy discomfort or other effects. The study will be done in different clinics across the UK, meaning you might go to your local participating clinic for these checks.

Potential risks and benefits

Taking part in this study could offer you the benefit of trying an updated nutritional product that might be more complete and easier to tolerate. Your feedback could also help improve care for others with similar health conditions. However, there's always a chance that you might not like the taste of the new formula, or it could cause some temporary tummy upsets. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Nutricia UK
Verified postcode
Trowbridge, United Kingdom· Recruiting

Common questions

What is an 'elemental diet'?

It's a special liquid food where nutrients are already broken down into very simple forms, making them easy for your body to absorb, especially if you have serious gut problems.

Who is this study for?

This study is for people aged 3 and over who already need an elemental diet because of severe gut issues or allergies.

How long will the study last?

The study will last for a total of 29 days, including one day of initial checks before starting the new diet for 28 days.

What will researchers be looking for?

They'll be checking if patients like the new formula, if they can stick to using it, and if it makes their tummy feel comfortable.

Will I get to choose between powder and liquid?

The study will test both powder and liquid forms. You will be assigned to one of these.

How to find out more

Isabel Evans

isabel.evans@nutricia.com +44 7385 000738 Official trial record

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