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The iAGE follow-up study reports that a heated cow’s milk protein powder product is safe and well-tolerated for daily oral immunotherapy in children with cow’s milk allergy.

Cow’s milk allergy (CMA) is a common food allergy in children that can cause various symptoms ranging from mild to severe. Avoiding cow’s milk protein completely is currently the only treatment option for CMA, which can be challenging. This study, published in the journal Nutrients, aimed to investigate the efficacy and safety of a novel heated cow’s milk protein powder, called the iAGE product, in children with CMA. 

The study included 18 children diagnosed with CMA, with ages ranging from 6.5 to 22.5 months. Eleven children were randomized to receive the iAGE product (treatment), while seven children formed the control group. No significant differences were found between the two groups, except for age and parental reports of asthmatic symptoms.

Tolerance to Cow’s Milk Improved in Children

At baseline, all children had a positive double-blind placebo-controlled food challenge (DBPCFC) with cow’s milk (CM). After the intervention, eight out of eleven children (73%) in the treatment group had a negative DBPCFC at t=1, compared to four out of seven (57%) in the control group. At t=3, nine out of eleven children (82%) in the treatment group and five out of seven (71%) in the control group were tolerant to CM. The difference between the treatment and control groups was largest at t=1.

Reduction in Specific IgE and Skin Prick Test Values in Children With CMA

The mean values for specific IgE and skin prick test (SPT) response to CM extract and components decreased in all children in both groups from the start to the end of intervention. The treatment group had a larger decrease in specific IgE to CM extract and a similar decrease in SPT compared to the control group.

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Safety of Heated Cow’s Milk Protein Powder for Cow’s Milk Allergy Treatment

Fifteen adverse events were reported during treatment, and most of them were considered unrelated to the use of the iAGE product. The proportion of children with adverse events did not differ between the treatment and control groups.

Introduction of Cow’s Milk Proteins After Treatment with iAGE Product

All 11 children in the treatment group consumed the iAGE product daily, indicating good compliance. Of the 14 children with a negative DBPCFC for CM at the end of the study, 13 successfully introduced CM proteins in their daily diet. Only one child experienced mild gastrointestinal symptoms, and most parents successfully fed their children the recommended minimum of 200 mL CM daily.

The study concluded that the iAGE product may help induce tolerance to CM, as demonstrated by a higher proportion of negative DBPCFC results in the treatment group compared to the control group. However, further studies are needed to confirm these findings.

van Boven, F. E., Arends, N. J. T., Sprikkelman, A. B., Emons, J. A. M., Hendriks, A. I., van Splunter, M., Schreurs, M. W. J., Terlouw, S., Gerth van Wijk, R., Wichers, H. J., Savelkoul, H. F. J., van Neerven, R. J. J., Hettinga, K. A., & de Jong, N. W. (2023). Tolerance Induction in Cow’s Milk Allergic Children by Heated Cow’s Milk Protein: The iAGE Follow-Up Study. Nutrients, 15(5). https://doi.org/10.3390/nu15051181