Kendamil CMPA Trial for ACBS Type II v.1
Research type
Research Study
Full title
7-Day Acceptability and Safety Study Of Extensively Hydrolysed Formula for Cow's Milk Protein Allergy Infants
IRAS ID
302419
Contact name
Dylan McMahon
Contact email
Sponsor organisation
Kendal Nutricare
Duration of Study in the UK
0 years, 3 months, 22 days
Research summary
Infants and children are commonly diagnosed with cow's milk protein allergy (CMA). It is one of the most common food allergies in early childhood, which peaks in the first year of life and then tends to subside. It is estimated that 5% to 15% of infants show symptoms that suggest adverse reactions to cow milk protein while In the developed world, the prevalence in infants appears to be 2 to 3%. CMA is an allergic reaction to the protein found in cow's milk and presents as a variety of symptoms and signs commonly developed by infants. Typically, the presence of cow's milk allergy appears within the first few months of life and usually before six months.
Extensively hydrolysed infant formulas are one of the essential foods for children with CMA. The aim of this study is to show that Kendamil Medi + CMA is safe and appropriate to use in children under 12 months of age. The results of this study will be a part of a submission to the Advisory Committee on Borderline Substances (ACBS) in order to obtain approval to Kendamil Medi + CMA will allow parents of children with CMA to choose a formula with the following advantageous characteristics:
• The formulation has no added palm oil. Palm oil added to infant formula can cause the formation of calcium soaps and induce constipation.
• Being predominantly whey protein, it has a better taste profile than 100% casein-based extensively hydrolysed formulas.
• Higher levels of DHA, known to be beneficial for brain development.
• DHA and ARA are algal derived, removing Fish as an allergen and allows the product to be vegetarian.
• Suitable for a vegetarian diet
• Suitable for a Halal diet, currently undergoing certification with the Halal Food Authority (HFA).REC name
South Central - Berkshire B Research Ethics Committee
REC reference
21/SC/0320
Date of REC Opinion
16 Nov 2021
REC opinion
Further Information Favourable Opinion