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Growth and gut comfort of healthy term infants exclusively fed with a partially hydrolysed protein-based infant
Paris Kantaras1, Anna Kokkinopoulou2, Jeske H J Hageman3
1Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece.
Insights
Partially hydrolysed infant formula (pHF) supports healthy infant growth, showing equivalence to intact protein formula (IPF). Both formulas were well-tolerated, with comparable gut comfort and safety profiles in infants.
Area of Science:
- Pediatric Nutrition
- Infant Formula Development
- Gastrointestinal Health in Infants
Background:
- Cow's milk protein allergy is a concern in infant feeding.
- Partially hydrolyzed formulas (pHF) are designed to reduce allergenicity.
- Evidence on growth and gut comfort equivalence of pHF versus intact protein formula (IPF) is important for clinical practice.
Purpose of the Study:
- To compare the growth outcomes of healthy infants fed with pHF versus IPF.
- To assess and compare the gut comfort and tolerance of infants consuming pHF versus IPF.
- To evaluate the safety and efficacy of pHF in comparison to IPF for infant nutrition.
Main Methods:
- A double-blind, multi-center, randomized controlled trial involving 345 healthy, exclusively formula-fed infants aged ≤28 days.
- Infants were allocated to receive either pHF (n=173) or IPF (n=172) until 17 weeks of age.
- Primary outcome: equivalence of weight gain; Secondary outcomes: growth parameters (weight, length, head circumference, BMI, Z-scores); Tertiary outcomes: gut comfort, formula intake, and adverse events.
Main Results:
- No significant differences in weight gain (g/d) were observed between the pHF and IPF groups over the 17-week intervention period (p=0.915).
- Equivalence in other growth parameters, including length, head circumference, BMI, and anthropometric Z-scores, was demonstrated for both groups.
- While stool consistency differed, gut comfort, stool frequency, and formula intake were comparable between the groups; adverse events were low and similar.
Conclusions:
- Partially hydrolyzed infant formula (pHF) supports adequate and equivalent infant growth compared to standard intact protein formula (IPF).
- The overall gut comfort and tolerance were comparable between infants fed pHF and IPF.
- pHF is demonstrated to be safe and well-tolerated in healthy infants, offering a viable alternative to IPF.
Objective:
This study aimed to investigate growth and gut comfort of healthy infants fed with a partially hydrolysed cow's milk protein-based infant formula (pHF) compared to a standard intact cow's milk protein-based formula (IPF).
Methods:
A double-blind, multi-center, randomized, controlled trial was performed. Healthy full-term, exclusively formula-fed infants (n = 345), aged ≤28 days were allocated to consume either a pHF (n = 173) or an IPF (n = 172) until the age of 17 weeks. The primary outcome was equivalence of weight gain (g/d) until the age of 17 weeks. The secondary outcomes were equivalence of other growth parameters, i.e., infants' weight, length, head circumference, body mass index (BMI) and anthropometric Z-scores, while tertiary outcomes were gut comfort, formula intake, and adverse events (AEs).
Results:
Overall, 288 infants completed the study (pHF group: 138, IPF group: 150). No differences were observed between the two groups in weight gain (g/d) during the three-months intervention [p = 0.915 for the Per Protocol (PP) population]. The 90% CI was [-1.252 to 1.100] being within the pre-defined equivalence margin of ±3.0 g/d. Similar findings were observed in the Full Analysis Set (FAS) and the sensitivity analysis. Regarding the secondary outcomes, no differences over the intervention period were shown between the two groups in both the PP and FAS analysis sets. Average Z-scores were in the normal range based on World Health Organization (WHO) growth standards for both groups at all time points in both analysis sets. Stool consistency, amount, and colour were different in the two groups. No differences were observed in gut comfort, stool frequency, and formula intake, between the two groups. In total 14 AEs and 22 serious adverse events (SAEs) were reported of which 15 (12%) and 1 (5%) were considered as (possibly) related to the study product, respectively.
Conclusions:
The study demonstrates that the consumption of pHF results in adequate infant growth, equivalent to that of infants consuming IPF. Furthermore, the overall gut comfort was comparable between the two groups. Therefore, it can be concluded that the pHF is safe for and well tolerated by healthy infants.
Clinical Trial Registration:
https://clinicaltrials.gov/study/NCT05757323?id=NCT05757323&rank=1, identifier (NCT05757323).
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