Growth, safety, and tolerance of a hydrolysed rice protein-based formula in infants with cow's milk allergy

Cow's milk allergy (CMA) is the most common food allergy in infants, requiring the use of hypoallergenic formulas when breastfeeding is not possible. Hydrolysed rice formulas (HRF) are now positioned alongside extensively hydrolysed cow's milk protein formulas as first line (nutritional) management of CMA in both European and International guidelines. This descriptive single-arm, multicentre interventional study (NCT05618704) evaluated growth, safety, and tolerance of a new HRF in infants with CMA.

Infants ≤8 months with CMA, diagnosed by their clinicians according to the local hospital practice, were recruited from clinics in Belgium, Poland and Spain. The infants (n = 69) were prescribed the new HRF and followed for 16 weeks. Adequate growth was assessed using WHO growth z-scores weight-for-age and weight-for-length. Allergic symptoms (assessed by the clinician using Cow's Milk-related Symptom Score [CoMiSS®]), gastrointestinal symptoms (reported in diaries by parents) and safety were monitored during the 16-week period. Growth and efficacy analyses were primarily conducted on infants who completed the 16-week observational period (n = 61), with sensitivity analyses performed in the all subjects treated (AST) population. Safety analyses were conducted on all infants that consumed the HRF (n = 68).

At baseline, mean age (±SD) was 3.17 ± 2.32 months. Over the 16-week period, increases in weight-for-age and weight-for-length were observed, with 92% of infants (56/61) meeting the predefined criteria for adequate growth. Sensitivity analyses in the AST population yielded consistent conclusions. Cow's milk related symptoms decreased over time; mean CoMiSS declined from 11.3 ± 3.4 at baseline to 2.1 ± 1.8 at 16 weeks, with reductions observed across all CMA diagnostic categories. Compared with baseline, parents reported reductions in gastrointestinal symptoms over the observation period. The overall parental opinion was that the formula was very good. No new safety signals were identified during the 16-week study period.

Infants with clinician-diagnosed CMA who received the new HRF for 16 weeks showed adequate growth and reductions in cow's milk related and gastrointestinal symptoms over time. The formula was well tolerated by infants and well accepted by parents, and no new safety signals were observed during the study period. These findings support the use of HRF as a nutritional option for the dietary management of CMA, in line with current guidelines.