RecruitingNot ApplicableNCT06633289
Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula in Infants and Young Children With Cow's Milk Protein Allergy
Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula in Infants and Young Children With Cow's Milk Protein Allergy: a Randomized Nutritional Clinical Study
Sponsor
Société des Produits Nestlé (SPN)
Enrollment
67 participants
Start Date
Nov 5, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 60 DaysMax Age: 3 Years
Inclusion Criteria6
- 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
Exclusion Criteria14
- Child is exclusively breastfed
- Any chronic medical diseases (except atopic eczema), chromosomal or major congenital anomalies
- Congenital heart disease or treatment by B-blockers
- Major gastrointestinal disease / abnormalities (other than CMPA)
- Known or suspected soy allergy
- Glucose-galactose malabsorption
- Immunodeficiency
- Children who are unable to discontinue antihistamine use (excluding eye drops) within 7 days prior to a food challenge and oral steroid use within 14 days prior to enrollment
- Persistent wheeze or chronic respiratory disease
- Severe uncontrolled eczema or urticaria
- Rice protein allergy or intolerance (e.g., rice protein-induced enterocolitis syndrome), or allergy to any ingredient in the formulas
- Child's parent has other medical or psychiatric condition that, in the judgement of the Investigator, would make the child inappropriate for entry into the study
- Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment
- Child's parents have not reached legal age of majority (18 years).
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Interventions
OTHERExperimental formula
New hydrolyzed rice protein-based formula
OTHERControl formula
Commercially available amino acid-based formula.
Locations(11)
View Full Details on ClinicalTrials.gov
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NCT06633289