Actively Recruiting
Hydrolysed Rice Formula Study
Led by Nutricia UK Ltd · Updated on 2026-04-13
86
Participants Needed
2
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Hydrolysed Rice Formula Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female
- Aged 0-13 months
- Presenting to primary or secondary care with symptoms or clinical history suggestive of cow's milk allergy
- Receiving at least 30% of energy requirements from the study formula
- Written informed consent provided by parent or carer
You will not qualify if you...
- Severe cow's milk allergy including anaphylaxis or requiring amino acid formula
- Faltering growth based on NICE guidelines
- Previous allergy to any study product ingredients, including whey hydrolysate or rice
- Primary lactose intolerance
- Food Protein-Induced Enterocolitis Syndrome (FPIES)
- Exclusively breastfed infants
- Severe chronic or concurrent disease or genetic syndrome affecting growth or outcomes
- Severe liver or kidney insufficiency
- Premature infants born before 37 weeks with corrected age under 4 weeks
- Need for any parenteral nutrition
- Participation in other clinical intervention studies within 1 month before recruitment
- Concerns about caregiver's willingness or ability to comply with study requirements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Gloucestershire Royal NHS Trust
Gloucester, Gloucestershire, United Kingdom, GL1 3NN
Actively Recruiting
2
Bristol Royal Hospital for Children
Bristol, Somerset, United Kingdom, BS16 1TA
Actively Recruiting
Research Team
I
Isabel Evans, MSc
CONTACT
G
Gary P Hubbard, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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