Growth, Safety and Tolerance of a Hydrolyzed Protein Infant Formula

The main purpose of this study is to demonstrate adequate growth over a 16-week intervention period in cow's milk allergic infants receiving a hydrolyzed protein formula.

Inclusion criteria

• Infants <8 months of age.
• Infants with a clinical diagnosis of Cow's Milk Allergy (CMA) per local hospital practice, including any of the following criteria:

• Based on clinical examination with a careful history, parent-reported symptoms suggestive of CMA, and disappearance of the symptoms when cow's milk was eliminated from the diet for at least two weeks prior to study entry
• Based on clinical examination with a careful history, parent-reported symptoms suggestive of CMA, and disappearance of the symptoms while being breastfed with maternal cow's milk protein elimination diet for at least two weeks prior to study entry
• History of CoMiSS® score >10 indicating symptoms are likely cow's milk allergic prior to study entry
• History of positive result of an oral food challenge with cow's milk prior to study entry
• Presence of specific Immunoglobulin E (IgE) to cow's milk protein based on skin prick test (wheel size ≥3mm) or radio-allergosorbent-test (RAST) (>0.7 kilounit per liter (kU/L)) prior to or on the day of study entry.
• 3. Infants that are still on dairy-derived extensively hydrolysed formula, amino acid-based formula, hydrolysed rice protein formula, soy-based formula or being breastfed by mothers who are on cow's milk protein elimination diet at study entry.
• Parents / guardians confirm their intention not to administer any products containing cow's milk protein during the study.
• Expected to consume the specified age-dependent minimum amount of study product per day during the study.
• Expected to require a milk substitute for CMA management for at least 16 weeks.
• Written informed consent provided by parents / guardians, according to local law.

Exclusion criteria

• Birth weight-for-age z-score <-2 Standard Deviation (SD) or >+2SD.
• Infants <37 weeks gestation requiring specific premature formula at the time of study entry.
• Infants with severe concurrent illness and/or have undergone gastrointestinal surgery such as bowel resection or stoma placement and/or with Down syndrome or other syndromes where functional gastrointestinal disorders are common.
• Infants that are more suitable to use Amino Acid Formula (AAF) as first-line formula, including but not limited to those with high risk of anaphylaxis (prior history of anaphylaxis and currently not using extensively Hydrolysed Formula (eHF)), faltering growth / failure to thrive, or severe forms of non-IgE-mediated CMA such as eosinophilic oesophagitis, enteropathies, or Food Protein-Induced Enterocolitis Syndrome (FPIES).
• Infants with diagnosis of rice allergy or known allergy to any of the ingredients in the study product.
• Investigator's uncertainty about the willingness or ability of the parents / guardians to comply with the protocol requirements.
• Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.