Effect of a Hydrolyzed Rice Protein-based Formula on Growth, Tolerance, and Health-related Quality of Life in Infants 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 special formula made from hydrolyzed rice protein to see how well it helps infants with cow's milk protein allergy (CMPA) grow and feel better. The main goal is to find out if babies who drink this new rice-based formula grow just as well as those who drink a standard formula without cow's milk. Researchers will also look at how well these babies tolerate the new formula, how it affects their quality of life, and how much they like it.

To participate in the study, infants must be under 8 months old, have a suspected CMPA, and be on a strict diet that eliminates cow's milk. Parents need to give their consent for their baby to join the study. Some conditions, like certain allergies or severe health issues, might prevent infants from being eligible. If a baby qualifies, parents can expect to provide the new formula for their child and share information about their baby's growth and health during the study. This trial has not started recruiting participants yet, but it aims to help improve nutrition options for infants 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. Infant gestational age ≥ 37 completed weeks
• • 3. Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg
• • 4. Singleton birth
• • 5. Infant age ≤ 8 months
• • 6. Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk
• 7. Suspected CMPA as per standard clinical practice and in conjunction with at least 2 symptoms present from the list shown below:
• • 1. Inconsolable crying, regurgitation, liquid stools or constipation, skin atopic lesion, cow's milk provoked temporary urticaria/angioedema or vomiting, bloody streaks in stool, or respiratory symptoms
• • 2. For diagnosis based on either a positive IgE blood test, skin prick test or food challenge, only at least 1 symptom from above list needs to be present
• • 8. Infant is receiving a strict cow's milk elimination diet and will continue receiving this diet until the completion of the study
• • 9. Infant's parent(s)/LAR is of legal age of majority, must have parental authority, must understand the informed consent form and other study documents, and is willing and able to fulfill the requirements of the study protocol
• Exclusion Criteria:
• • 1. History of intolerance to eHF formula
• • 2. Any chronic medical diseases (except atopic eczema), chromosomal or major congenital anomalies (based on medical history and/or commonly performed diagnostic criteria)
• • 3. Major gastrointestinal disease / abnormalities (other than CMPA)
• • 4. Known or suspected lactose intolerance or malabsorption
• • 5. Known or suspected soy allergy
• • 6. Glucose-galactose malabsorption
• • 7. Rice protein allergy or intolerance (e.g., rice protein-induced enterocolitis syndrome).
• • 8. Immunodeficiency
• • 9. Persistent wheeze or chronic respiratory disease
• • 10. Severe uncontrolled eczema
• • 11. History of severe anaphylactic reaction (e.g., requiring ≥ 2 doses of epinephrine) to cow's milk or breast milk at any time prior to enrollment
• • 12. Weight-for-age value \< -2 or \> 2 standard deviations from the WHO Child Growth Standards median at enrollment
• • 13. Height-for-age \< -2 or \> 2 standard deviations from the WHO Child Growth Standards median at enrollment
• • 14. Infant's parent has other medical or psychiatric condition that, in the judgement of the investigator, would make the infant inappropriate for entry into the study
• • 15. Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment