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Study identifier: NCT06288503 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Hydrolysed Rice Formula Study

Condition: Cow's Milk Protein Allergy  ·  Sponsor: Nutricia UK Ltd

PhaseNA
Planned participants86
Who can joinAll sexes, 0 Months to 13 Months
Healthy volunteersNo

About this 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.

This description comes directly from the study's public registry record.

Talk to the study team

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

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

Always discuss trial participation with your own doctor first.

Locations (2)

Gloucestershire Royal NHS TrustGloucester, Gloucestershire, United KingdomRecruiting
Bristol Royal Hospital for ChildrenBristol, Somerset, United KingdomRecruiting

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Source record: clinicaltrials.gov/study/NCT06288503