Hydrolysed Rice Formula Study

Nutricia

Status: Enrolling

Conditions: Cow's Milk Protein Allergy

Treatments: Other: Hydrolysed Rice Protein Formula; Other: Cow's Milk Based Extensively Hydrolysed Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT06288503

HRF2023

Details and patient eligibility

About

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.

Enrollment: 86 estimated patients

Sex: All

Ages: Under 13 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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86 participants in 2 patient groups

Intervention

Experimental group

Description:

Hydrolysed rice protein formula

Treatment:

Other: Hydrolysed Rice Protein Formula

Control

Active Comparator group

Description:

Cow's milk based extensively hydrolysed formula

Treatment:

Other: Cow's Milk Based Extensively Hydrolysed Formula