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Analysis of immune, microbiota and metabolome maturation in infants in a clinical trial of Lactobacillus paracasei CBA L74-fermented formula.

Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy. paola.roggero@unimi.it. Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy. paola.roggero@unimi.it. Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy. Humanitas Clinical and Research Center-IRCCS, Via Manzoni 56, 20089 Rozzano, Milan, Italy. Theoreo Srl, Via degli Ulivi 3, 84090, Montecorvino Pugliano, SA, Italy. European Biomedical Research Institute of Salerno (EBRIS), Via S. de Renzi, 3, 84125, Salerno, SA, Italy. Department of Medicine, Surgery and Dentistry, "Scuola Medica Salernitana", Neuroscience Section, University of Salerno, Baronissi, SA, Italy. Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy. Department of Translational Medical Science, University Federico II, Naples, Italy. ImmunoNutritionLab at CEINGE-Biotecnologie Avanzate s.c.ar.l., University Federico II, Naples, Italy. European Laboratory for the Investigation of Food-Induced Diseases, University Federico II, Naples, Italy. Task Force on Microbiome Studies, University Federico II, Naples, Italy. School of Engineering, Niccoló Cusano University, Rome, Italy. Humanitas Clinical and Research Center-IRCCS, Via Manzoni 56, 20089 Rozzano, Milan, Italy. maria.rescigno@hunimed.eu. Humanitas University Department of Biomedical Sciences, Via Rita Levi Montalcini 4, 20090 Pieve Emanuele, Milan, Italy. maria.rescigno@hunimed.eu.

Nature communications. 2020;(1):2703
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Abstract

Mother's milk is the best choice for infants nutrition, however when it is not available or insufficient to satisfy the needs of the infant, formula is proposed as an effective substitute. Here, we report the results of a randomized controlled clinical trial (NCT03637894) designed to evaluate the effects of two different dietary regimens (standard formula and Lactobacillus paracasei CBA L74-fermented formula) versus breastfeeding (reference group) on immune defense mechanisms (primary endpoint: secretory IgA, antimicrobial peptides), the microbiota and its metabolome (secondary outcomes), in healthy full term infants according to the type of delivery (n = 13/group). We show that the fermented formula, safe and well tolerated, induces an increase in secretory IgA (but not in antimicrobial peptides) and reduces the diversity of the microbiota, similarly, but not as much as, breastmilk. Metabolome analysis allowed us to distinguish subjects based on their dietary regimen and mode of delivery. Together, these results suggest that a fermented formula favors the maturation of the immune system, microbiota and metabolome.

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Publication Type : Randomized Controlled Trial

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