Clinical Research Directory
Browse clinical research sites, groups, and studies.
Hydrolysed Rice Formula Study
Sponsor: Nutricia UK Ltd
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.
Official title: 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
Key Details
Gender
All
Age Range
0 Months - 13 Months
Study Type
INTERVENTIONAL
Enrollment
86
Start Date
2024-02-01
Completion Date
2027-07
Last Updated
2025-02-26
Healthy Volunteers
No
Conditions
Interventions
Hydrolysed Rice Protein Formula
Infants randomised onto this arm will be taking the hydrolysed rice protein formula, with a minimum prescription of 30% of their energy requirements.
Cow's Milk Based Extensively Hydrolysed Formula
Infants randomised onto this arm will be taking the control product, with a minimum prescription of 30% of their energy requirements.
Locations (2)
Gloucestershire Royal NHS Trust
Gloucester, Gloucestershire, United Kingdom
Bristol Royal Hospital for Children
Bristol, Somerset, United Kingdom