Hydrolysed Rice Formula Study
A Double-blind, Randomised-controlled Trial Evaluating a Hydrolysed Rice Formula Compared to a Cow's Milk Protein-based Extensively Hydrolysed Formula in Infants With Cow's Milk Allergy
Nutricia UK Ltd
86 participants
Feb 1, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
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Interventions
Infants randomised onto this arm will be taking the hydrolysed rice protein formula, with a minimum prescription of 30% of their energy requirements.
Infants randomised onto this arm will be taking the control product, with a minimum prescription of 30% of their energy requirements.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06288503