About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Hydrolysed Rice Protein Formula
- Cow's Milk Based Extensively Hydrolysed Formula