Hydrolysed Rice Formula Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-13
SponsorNutricia UK Ltd

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

Treatment groups

86 Participants
are divided into 2 treatment groups

Sponsors and collaborators