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.
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: a Randomized Nutritional Clinical Study
Société des Produits Nestlé (SPN)
104 participants
Oct 25, 2024
INTERVENTIONAL
Conditions
Summary
The main purpose of this study is to demonstrate that the growth of infants fed with the Test Formula is non-inferior those fed with the Control Formula. The study will also evaluate the gastrointestinal tolerance, quatliy of life and acceptability of the new rice protein-based formula in infants with cow's milk protein allergy (CMPA).
Eligibility
Inclusion Criteria11
- Written informed consent has been obtained from at least one parent (or legally acceptable representative \[LAR\]), if applicable)
- Infant gestational age ≥ 37 completed weeks
- Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg
- Singleton birth
- Infant age ≤ 8 months
- Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk
- Suspected CMPA as per standard clinical practice and in conjunction with at least 2 symptoms present from the list shown below:
- 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
- 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
- Infant is receiving a strict cow's milk elimination diet and will continue receiving this diet until the completion of the study
- 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 Criteria15
- History of intolerance to eHF formula
- Any chronic medical diseases (except atopic eczema), chromosomal or major congenital anomalies (based on medical history and/or commonly performed diagnostic criteria)
- Major gastrointestinal disease / abnormalities (other than CMPA)
- Known or suspected lactose intolerance or malabsorption
- Known or suspected soy allergy
- Glucose-galactose malabsorption
- Rice protein allergy or intolerance (e.g., rice protein-induced enterocolitis syndrome).
- Immunodeficiency
- Persistent wheeze or chronic respiratory disease
- Severe uncontrolled eczema
- 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
- Weight-for-age value < -2 or > 2 standard deviations from the WHO Child Growth Standards median at enrollment
- Height-for-age < -2 or > 2 standard deviations from the WHO Child Growth Standards median at enrollment
- 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
- Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment
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Interventions
Hydrolyzed rice protein formula
Commercially available extensively hydrolyzed cow's milk formula
Locations(19)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06633250