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
Inclusion Criteria5
- 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 Criteria12
- 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
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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
For the most up-to-date information, visit the official listing.
NCT06288503