Hydrolysed Rice Formula Study

NCT06288503 | Recruiting

• 1 other identifier: HRF2023
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cow's Milk Protein Allergy

Outcome Measures

Primary Outcomes (1)

• Growth

  At Baseline (Day 1), End of Intervention (Day 31), and Follow-Up (Day 87) assessments, length and head circumference will be measured using standard measures to the nearest 0.1cm. Body weight (kg) will also be measured, where possible, by the investigating Dietitian/relevant HCP using standard methods to the nearest 0.1kg using a weighing scale without heavy clothing. These measures will be used to calculate z-scores (i.e., weight-for-length, weight, length, and head circumference; based on UK-WHO 2006 growth reference data for children 0-4 years old) and plotted on growth charts for centile measurement.

  Baseline to three months

Secondary Outcomes (11)

• Gastrointestinal Tolerance

  Baseline to three months

• Stool frequency and consistency

  Baseline to three months

• Study Product Intake

  Baseline to three months

• Patient Orientated Scoring Atopic Dermatitis Symptoms (PO-SCORAD)

  Baseline to three months

• Patient Reported Atopic Symptoms

  Baseline to three months

Study Arms (2)

Intervention

EXPERIMENTAL

Hydrolysed rice protein formula

Other: Hydrolysed Rice Protein Formula

Control

ACTIVE COMPARATOR

Cow's milk based extensively hydrolysed formula

Other: Cow's Milk Based Extensively Hydrolysed Formula

Interventions

Cow's Milk Based Extensively Hydrolysed Formula OTHER

Infants randomised onto this arm will be taking the control product, with a minimum prescription of 30% of their energy requirements.

Control

Hydrolysed Rice Protein Formula OTHER

Infants randomised onto this arm will be taking the hydrolysed rice protein formula, with a minimum prescription of 30% of their energy requirements.

Intervention

Eligibility Criteria

• Age: 0 Months - 13 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nutricia UK Ltd: lead

Study Sites (2)

Gloucestershire Royal NHS Trust

Gloucester, Gloucestershire, GL1 3NN, United Kingdom

RECRUITING

Bristol Royal Hospital for Children

Bristol, Somerset, BS16 1TA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Isabel Evans, MSc

CONTACT

07385000738; Isabel.EVANS@danone.com

Gary P Hubbard, PhD

CONTACT

07738024720; gary.hubbard@nutricia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: March 1, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)