Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula in Infants and Young Children With Cow's Milk Protein Allergy

Launched by SOCIÉTÉ DES PRODUITS NESTLÉ (SPN) · Oct 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new formula made from hydrolyzed rice protein to see if it is safe for infants and young children who have a cow's milk protein allergy (CMPA). CMPA is a condition where the body has an allergic reaction to proteins found in cow's milk, which can cause various symptoms. The goal of the study is to find out if this rice-based formula is hypoallergenic, meaning it is less likely to cause allergic reactions in children who are already sensitive to cow's milk.

To participate in this trial, children must be between 2 months and 3 years old, have been diagnosed with IgE-mediated CMPA within the last 6 months, and be on a strict diet that excludes cow's milk. Parents or guardians will need to provide consent for their child to participate. The trial has specific rules about who can join, so certain conditions, like other allergies or health issues, may prevent some children from being eligible. If chosen, families can expect to continue the milk-free diet while monitoring how the new formula works for their child. This study is not yet recruiting participants, but it aims to provide valuable information about dietary options for children with CMPA.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • 1. Written informed consent has been obtained from at least one parent (or legally acceptable representative \[LAR\]), if applicable)
• • 2. Child gestational age ≥ 37 completed weeks
• • 3. Child aged ≥ 60 days and less than 36 months at enrollment
• • 4. Documented IgE-mediated CMPA no more than 6 months prior to enrollment
• • 5. Child is receiving a strict cow's milk elimination diet and will continue receiving this diet until the completion of the study
• • 6. 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 criteria:
• • 1. Child is exclusively breastfed
• • 2. Any chronic medical diseases (except atopic eczema), chromosomal or major congenital anomalies
• • 3. Congenital heart disease or treatment by B-blockers
• • 4. Major gastrointestinal disease / abnormalities (other than CMPA)
• • 5. Known or suspected soy allergy
• • 6. Glucose-galactose malabsorption
• • 7. Immunodeficiency
• • 8. 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
• • 9. Persistent wheeze or chronic respiratory disease
• • 10. Severe uncontrolled eczema or urticaria
• • 11. Rice protein allergy or intolerance (e.g., rice protein-induced enterocolitis syndrome), or allergy to any ingredient in the formulas
• • 12. 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
• • 13. Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment
• • 14. Child's parents have not reached legal age of majority (18 years).