Gastrointestinal Tolerance of an Infant Formula Manufactured from Extensively Hydrolysed Protein in Healthy Term Infants.

The evaluation of secondary parameters of a prospective, randomised, controlled, multicentre intervention trial aimed to analyse gastrointestinal tolerance of an infant formula manufactured from extensively hydrolysed whey protein (eHF) compared to intact cow's milk protein (control formula, CF) in healthy term infants. Infants ≤ 25 days of age, who were exclusively formula-fed, were randomised to receive eHF or CF for at least three months up to 120 days of age. An exclusively breastfed reference group (BF) was included for descriptive comparison. Infants' gastrointestinal tolerance was evaluated based on stool parameters, the Amsterdam Infant Stool Scale (AISS), the Infant Gastrointestinal Symptom Questionnaire (IGSQ), and sleeping patterns. Of 359 infants included, 297 randomised (eHF: n = 149, CF: n = 148) and 41 BF infants completed the study per protocol. All tolerance parameters were comparable between eHF and CF. Stool was predominantly soft and yellow in colour. Stool was more frequently green in eHF than CF. BF infants had more frequent stools, which were mainly watery or soft and yellow, and comparable IGSQ scores (descriptive). Irrespective of group, all gastrointestinal and sleep parameters showed signs of maturation with increasing age. In conclusion, eHF showed gastrointestinal tolerance as good as CF in healthy infants. Both formulae were well-tolerated.

Correction: Otten et al. Safety and Suitability of an Infant Formula Manufactured from Extensively Hydrolysed Protein in Healthy Term Infants. Nutrients 2023, 15, 1901.

In the original publication [...].

Safety and Suitability of an Infant Formula Manufactured from Extensively Hydrolysed Protein in Healthy Term Infants.

We aimed to demonstrate that healthy term infants experience noninferior growth with infant formula manufactured from extensively hydrolysed whey protein (eHF) compared to intact cow's milk protein (control formula, CF). This prospective, randomised, double-blind, parallel-group, controlled, multicentre trial included healthy term infants who were exclusively formula-fed. Infants ≤ 25 days of age received eHF or CF for at least three months up to 120 days of age, with a follow-up until 180 days of age. A reference group included exclusively breastfed infants (BF). Of 318 infants randomised, 297 (148 CF, 149 eHF) completed the study per protocol. Weight gain up to 120 days of age was noninferior (margin -3.0 g/day) in eHF (28.95 (95% CI: 27.21; 30.68) g/day) compared to CF (28.85 (95% CI: 27.10; 30.61) g/day) with a difference in means of 0.09 g/day and a lower limit of the one-sided 97.5% CI of -0.86 g/day (p < 0.0001 for noninferiority testing). Weight gain remained comparable during follow-up. Further anthropometric parameters did not differ between the infant formula groups throughout the study. Growth was comparable in BF. No relevant safety issues were observed. To conclude, eHF meets infant requirements for adequate growth during the first six months of life and can be considered safe and suitable.