Hydrolysed rice protein formula for infants with cow's milk allergy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This non-inferiority study evaluates the effectiveness of a hydrolysed rice protein formula compared to a cow's milk protein-based extensively hydrolysed formula in infants aged 0-13 months who show symptoms of cow's milk allergy. The study employs a double-blind, randomised-controlled design over a 28-day intervention period, followed by a 2-month follow-up. Primary outcomes focus on growth, while secondary outcomes include gastrointestinal tolerance, allergic symptoms, parental quality of life, and safety. Participants will receive at least 30% of their energy requirements from the study formula.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female
* Aged 0-13 months
* Presenting to primary or secondary care with symptoms/clinical history suggestive of CMA
* Will receive at least 30% of energy requirements from the study formula
* Written informed consent from parent/carer

Exclusion Criteria:

* Severe CMA (including anaphylaxis) and/or requiring an AAF
* Faltering growth (based on NICE guidelines36 - Appendix 1)
* Previous allergy to any study product ingredients (including whey hydrolysate and/or rice)
* Primary lactose intolerance
* Food Protein-Induced Enterocolitis Syndrome (FPIES)
* Exclusively breast fed
* Severe concurrent or chronic disease or genetic syndrome that may impact growth or other outcomes
* Severe hepatic or renal insufficiency
* Premature infants (born \<37 weeks) with a corrected age of \<4 weeks
* Requirement for any parenteral nutrition
* Participation in other clinical intervention studies within 1 month of recruitment
* Concern around the willingness/ability of the caregiver to comply with the study protocol and/or study requirements

Where it's running

• Gloucestershire Royal NHS Trust
  Gloucester, Gloucestershire, United Kingdom Recruiting
• Bristol Royal Hospital for Children
  Bristol, Somerset, United Kingdom Recruiting

Study contacts

• Study coordinator: Isabel Evans, MSc
• Email: Isabel.EVANS@danone.com
• Phone: 07385000738

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.