Hydrolysed Rice Formula Study
Research type
Research Study
Full 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
IRAS ID
327003
Contact name
Rebecca Stratton
Contact email
Sponsor organisation
Nutricia UK Ltd
Duration of Study in the UK
4 years, 2 months, 31 days
Research summary
Cow’s milk allergy (CMA) is one of the most common childhood food allergies, affecting ~2-5% of infants in Europe. It is defined as a reproducible, immune-mediated response to one or more of the proteins which mainly constitute whey and casein in cow’s milk. There are two different types of CMA, termed immunoglobulin E (IgE) and non-IgE mediated, which are classified by the mechanism and timing of the immune reaction and its associated symptoms. CMA has a significant impact on parental quality of life (QOL) and places noteworthy economic burden on healthcare services. Hence, early detection and effective management of CMA is needed.
Management of CMA requires strict exclusion of cow’s milk protein (CMP) from the diet. Whilst breastmilk remains the ideal nutrient source for infants with CMA, infants who are not exclusively breastfed require a formula adapted for CMA dietary management, e.g., a hypoallergenic formula (HAF). Cow’s milk protein-based extensively hydrolysed formulae (CMP-eHF) are typically used first line in the majority of formula-fed infants with CMA. However, over recent years, there has been a rapidly increasing global interest in reducing animal-derived product use and increasing plant-based food consumption. This includes infants whose parents may or may not be following a plant-based diet themselves, but wish for their child to follow a plant-based diet from birth. Use of hydrolysed rice formulas (HRF) is well established in some European countries; however, at present, there are no HRF available for infants with CMA in the UK, despite the need for plant-based formulae. Furthermore, few randomised-controlled trials (RCTs) have been conducted comparing CMP-based eHF with HRF, highlighting the need for more robust data to inform clinical practice.
This non-inferiority study aims to determine whether a HRF is as effective as a CMP-based eHF 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 CMA. The primary outcome is growth, and secondary outcomes are gastrointestinal (GI) tolerance, and differences in intake, allergic symptoms, parental QOL, acceptability, dietary intake, and safety. The study is being conducted to meet the requirements for the Advisory Committee on Borderline Substances (ACBS) and the General Medical Services Scheme (GMS) for reimbursement in the UK and Ireland.
REC name
Wales REC 6
REC reference
23/WA/0190
Date of REC Opinion
28 Jul 2023
REC opinion
Further Information Favourable Opinion