RecruitingNAINTERVENTIONAL

Hydrolysed Rice Formula Study

This study is comparing a new rice-based baby formula with a well-known cow's milk-free formula. We're looking for babies aged 0-13 months who show signs of a cow's milk allergy. The main goal is to see if the rice formula helps babies grow just as well as the other formula. We'll also check how well babies tolerate it, if their allergic symptoms improve, and how satisfied parents are. The study lasts for 28 days, followed by a two-month check-up period.

At a glance

Status

Recruiting

Phase

Sponsor

Nutricia UK Ltd

Enrolment target

Start

01 Feb 2024

Estimated completion

01 Jul 2027

Cow's Milk Protein Allergy

What is this study about?

This study is designed to help us understand the best ways to feed babies who might have a cow's milk allergy. Many babies react badly to cow's milk, and there are special formulas available to help. This research is comparing two types of these special formulas.

One formula is a new option made from rice protein. The other is a commonly used formula where the cow's milk protein has been broken down to make it easier for babies to digest. By comparing them, we want to find out if the rice-based formula is just as good, or "non-inferior," for babies with suspected cow's milk allergy.

Over a short period, we'll carefully watch how babies grow and if their allergic symptoms improve. We'll also consider how easy the formulas are for babies to drink and how parents feel about them. This information will help doctors recommend the most suitable formula for babies with cow's milk allergies in the future.

Key takeaways

Compares a new rice formula to a current cow's milk-free formula.
For babies 0-13 months with suspected cow's milk allergy.
Aims to see if the rice formula helps babies grow just as well.
Looks at tummy comfort and allergic symptoms.
Study lasts 28 days with a 2-month follow-up.

Who may be eligible?

This study is looking for babies between birth and 13 months old who have symptoms that suggest they might have a cow's milk allergy. To join, a parent or guardian must be able to give written permission.

Your baby would not be able to join if they have a very severe cow's milk allergy (like anaphylaxis) or need a very specific 'amino acid' formula. We also can't include babies who aren't growing well for other reasons, or who have other serious health problems affecting their growth or kidneys/liver. Babies who are only breastfed or have a known allergy to any of the formula ingredients also can't take part.

Finally, babies born very early (before 37 weeks) won't be suitable until they are at least four weeks old (corrected for prematurity). We also need to be sure that families can follow the study plan easily.

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 baby 0-13 months old?
Does your baby show signs of a cow's milk allergy?
Is your baby mostly formula-fed (or will be)?
Does your baby not have a very severe cow's milk allergy?
Is your baby growing well for their age?

Answer every question to see your result.

What does participation involve?

If your baby takes part, they will be given one of the two study formulas. They will need to get at least 30% of their daily energy from this formula. We won't know which formula your baby is receiving, and neither will your doctor, which helps us get unbiased results. The main part of the study lasts for 28 days, during which we'll monitor your baby's growth and general health. After this, there will be a follow-up period of two months, where we'll continue to check on your baby's progress and any allergic symptoms. We'll also ask parents about their quality of life, how acceptable they find the formula, and collect information on what your baby eats.

Potential risks and benefits

Taking part in this study could help us learn more about effective formulas for cow's milk allergy, potentially benefiting many babies. While we don't expect serious problems, there's always a small chance of unexpected reactions to any food product. All formulas are carefully checked for safety. You are free to withdraw your baby from the study at any time, for any reason, without it affecting your baby's medical care.

Locations (2)

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

Gloucestershire Royal NHS Trust
Verified postcode
Gloucester, United Kingdom· Recruiting
Bristol Royal Hospital for Children
Verified postcode
Bristol, United Kingdom· Recruiting

Common questions

What is cow's milk protein allergy?

It's when a baby's immune system reacts badly to the proteins found in cow's milk, causing symptoms like skin rashes, tummy problems, or breathing difficulties.

What is a 'hydrolysed' formula?

It's a formula where the proteins are broken down into smaller pieces, making them easier for a baby's body to digest and less likely to cause an allergic reaction.

Will I know which formula my baby is getting?

No, this is a 'double-blind' study, meaning neither you nor the doctors will know which formula your baby receives. This helps ensure fair and accurate results.

How long will my baby be in the study?

The main part of the study lasts for 28 days, followed by a two-month period where we'll continue to check on your baby's health.

What does 'non-inferiority' mean?

It means we want to see if the new rice formula is just as good as, or at least not worse than, the standard formula currently used.

How to find out more

Isabel Evans, MSc

isabel.evans@danone.com 07385000738 Official trial record

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