NCT06288503

Hydrolysed Rice Formula Study

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Nutricia UK Ltd · Industry
• Sex: All
• Age: 0 Months – 13 Months
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Hydrolysed Rice Protein Formula	Infants randomised onto this arm will be taking the hydrolysed rice protein formula, with a minimum prescription of 30% of their energy requirements.
OTHER	Cow's Milk Based Extensively Hydrolysed Formula	Infants randomised onto this arm will be taking the control product, with a minimum prescription of 30% of their energy requirements.

Timeline

• Start date: 2024-02-01
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2024-03-01
• Last updated: 2026-04-13

Locations

2 sites across 1 country: United Kingdom