Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula in Infants and Young Children With Cow's Milk Protein Allergy: a Randomized Nutritional Clinical Study
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of the study is to determine whether a new hydrolyzed rice protein-based formula is hypoallergenic in infants and young children with documented Immunoglobulin E (IgE)-mediated Cow Milk Protein Allergy (CMPA).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2 months
Maximum Age: 3
Healthy Volunteers: f
View:
• Written informed consent has been obtained from at least one parent (or legally acceptable representative \[LAR\]), if applicable)
• Child gestational age ≥ 37 completed weeks
• Child aged ≥ 60 days and less than 36 months at enrollment
• Documented IgE-mediated CMPA no more than 6 months prior to enrollment
• Child is receiving a strict cow's milk elimination diet and will continue receiving this diet until the completion of the study
• Child's parent(s) and LAR (if applicable) is of legal age of majority, must have parental authority, must understand the informed consent form and other study documents, and are willing and able to fulfill the requirements of the study protocol
Locations
Other Locations
Germany
Charité - Universitätsmedizin Berlin Klinik für Pädiatrie m.S. Pneumologie/Immunologie
Wojewodzki Szpital Specjalistyczny im. M. Kopernika
NOT_YET_RECRUITING
Lodz
BioMedical Centers sp. z o.o.
NOT_YET_RECRUITING
Warsaw
Pediatrics Department at the Medical University of Warsaw
NOT_YET_RECRUITING
Warsaw
Contact Information
Primary
Julia Mauger
julia.mauger@rdls.nestle.com
(+41) 79 201 9835
Time Frame
Start Date:2024-11-05
Estimated Completion Date:2026-10
Participants
Target number of participants:67
Treatments
Other: Experimental formula-Control formula
Blinded cross-over oral food challenge sequence starting by Experimental formula followed by Control.~Following the crossover phase, children who passed the oral food challenge will consume the open label experimental formula at home during 7 days.
Other: Control formula-Experimental formula
Blinded cross-over oral food challenge sequence starting by Control followed by Experimental formula.~Following the crossover phase, children who passed the oral food challenge will consume the open label experimental formula at home during 7 days.