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bioRxiv · 10.64898/2026.08.12.744500

Evaluation of a Novel Recombinant Human Protein Formula Compared to Donor Human Milk and Standard Formula in Neonatal Piglets

Elefson, S.·Melendez Hebib, V.·Hoeprich, G.·Lau, J.·de Macedo Robert, J.·Wanessa Santana de Souza, M.·Ramalho Silva, M.·Vonderohe, C.·Guthrie, G.·Stoll, B.·Alfonso, D.·Burrin, D.
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Abstract

BackgroundDespite the advancements in infant nutrition, a gap still exists in the nutritional composition bioactive ingredients between infant formula and human milk. We developed a next-generation, proof-of-concept infant formula that contains recombinant human milk proteins. ObjectiveTo determine the impact of a novel infant formula (H1) on organ growth and development, and intestinal function compared to donor human milk (DHM) and standard infant formula (S) in a term piglet model. MethodsTerm piglets delivered via cesarean section were fed either a donor human milk (DHM) control, the investigational formula (H1), or infant formula (S) for 10 days. On d 10, a blood sample and tissues were collected. ResultsThere was no difference (P > 0.05) in piglet growth, although H1 piglets had a smaller relative stomach and liver than DHM and S piglets. H1 piglets had higher (P < 0.05) interleukins in the distal ileum, but no other systemic cytokines were elevated compared to the DHM and S piglets. H1 piglet small intestinal histology was similar (P > 0.05) to that of DHM and S piglets. Additionally, H1 piglets had either the same (P > 0.05) or higher (P < 0.05) amino acids in circulation compared to DHM and S piglets. Recombinant human proteins had either similar (P > 0.05) or lower (P < 0.05) activity compared to the native human proteins when assessing the individual ingredients in the H1 formula. ConclusionH1 formula was noninferior to DHM and S based on growth, small intestinal histology and plasma amino acid endpoints when fed to neonatal piglets. These findings warrant further studies to use the neonatal piglet as a model to evaluate more in-depth outcomes of health and safety for new infant formulas. Lay SummaryA novel piglet study shows a hypoallergenic, next-generation infant formula containing recombinant human milk proteins rivals donor human milk and standard formula for growth, gut health, and nutrient status.

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Elefson, S., Melendez Hebib, V., Hoeprich, G., Lau, J., de Macedo Robert, J., Wanessa Santana de Souza, M., Ramalho Silva, M., Vonderohe, C., Guthrie, G., Stoll, B., Alfonso, D., Burrin, D.. 2026-08-20. Evaluation of a Novel Recombinant Human Protein Formula Compared to Donor Human Milk and Standard Formula in Neonatal Piglets. https://doi.org/10.64898/2026.08.12.744500

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