Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Isabel Evans, MSc 07385000738
Isabel.EVANS@danone.com


Gary P Hubbard, PhD 07738024720
gary.hubbard@nutricia.com


Study Location:

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Be Part of Research - Trial Details - Hydrolysed Rice Formula Study

Hydrolysed Rice Formula Study

Recruiting

Open to: ALL

Age: 0.0 - 1.0833333333333333

Medical Conditions

Cow's Milk Protein Allergy


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This non-inferiority study aims to determine whether a hydrolysed rice protein formula is as effective as a cow's milk protein based extensively hydrolysed formula using a double-blind, randomised-controlled design over a 28-day intervention period followed by a 2-month follow-up period in infants 0-13 months of age presenting with symptoms/clinical history suggestive of cow's milk allergy. The primary outcome is growth, and secondary outcomes are gastrointestinal tolerance, and differences in intake, allergic symptoms, parental QOL, acceptability, dietary intake, and safety.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Feb 2024 Jul 2027

INTERVENTIONAL

Intervention Type : OTHER
Intervention Description : Infants randomised onto this arm will be taking the hydrolysed rice protein formula, with a minimum prescription of 30% of their energy requirements.

Intervention Arm Group : Intervention;

Intervention Type : OTHER
Intervention Description : Infants randomised onto this arm will be taking the control product, with a minimum prescription of 30% of their energy requirements.

Intervention Arm Group : Control;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Gloucestershire Royal NHS Trust
    Gloucester
    Gloucestershire
    GL1 3NN
  • Bristol Royal Hospital for Children
    Bristol
    Somerset
    BS16 1TA


The study is sponsored by Nutricia UK Ltd




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Read full details for Trial ID: NCT06288503
Last updated 24 February 2025

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