Trial reportJournal of pediatric gastroenterology and nutrition2025
Immunological effects of alpha-lactalbumin-enriched low-protein infant formula: A randomized controlled trial.
Trial report in Journal of pediatric gastroenterology and nutrition, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Immunological effects of alpha-lactalbumin-enriched low-protein infant formula: A randomized controlled trial.Journal of pediatric gastroenterology and nutrition · 2025Trial
- Human Milk as a Model for Next-Generation Infant Formula: Opportunities and Challenges.Advances in nutrition (Bethesda, Md.) · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
objectivesBreast-fed (BF) have lower risk of infections during infancy compared to those formula-fed (FF). A higher content of alpha-lactalbumin (α-lac) in breast milk, which may promote a more favorable gut microbiota, could be one reason. In this study, we evaluated whether increased concentration of α-lac in low-protein infant formula affects the immune response and the incidence of infections during infancy.
methodsIn a double-blinded randomized controlled trial, healthy-term infants (n = 245) received low-protein infant formulas with α-lac-enriched whey (α-lac-EW; 1.75 g protein/100 kcal, 27% α-lac) or casein glycomacropeptide-reduced whey (CGMP-RW; 1.76 g protein/100 kcal, 14% α-lac), or standard formula (SF; 2.2 g protein/100 kcal, 10% α-lac) from 2 to 6 months. BF constituted a reference group. Cytokines and high-sensitivity C-reactive protein (hsCRP) were measured during intervention and infection-related morbidity, and treatment was evaluated until 12 months.
resultsSerum interleukin-6 (IL-6) was lower in BF than in all FF groups during intervention (p < 0.001). No other differences in cytokines (tumor necrosis factor alpha [TNF-α], transforming growth factor beta 1 [TGF-β1], TGF-β2, IL-1, IL-10, IL-12, interferon gamma [INF-γ]) or hsCRP were found among the study groups. Infection-related morbidity did not differ among study groups, except slight differences in the use of antibiotics during (α-lac-EW vs. CGMP-RW [p = 0.008]) and after intervention (α-lac-EW vs. BF [p = 0.016]).
conclusionsIncreased α-lac concentration in low-protein infant formula to levels similar to breast milk did not affect the cytokine profile and had minor effect on infection-related morbidity. The higher IL-6 concentrations in FF than in BF needs further investigation.
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