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
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 1
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Bristol Royal Hospital for Children
RECRUITING
Bristol
Gloucestershire Royal NHS Trust
RECRUITING
Gloucester
Contact Information
Primary
Isabel Evans, MSc
Isabel.EVANS@danone.com
07385000738
Backup
Gary P Hubbard, PhD
gary.hubbard@nutricia.com
07738024720
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2027-07
Participants
Target number of participants: 86
Treatments
Experimental: Intervention
Hydrolysed rice protein formula
Active_comparator: Control
Cow's milk based extensively hydrolysed formula
Related Therapeutic Areas
Sponsors
Leads: Nutricia UK Ltd

This content was sourced from clinicaltrials.gov