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

Paola Roggero (), Nadia Liotto, Chiara Pozzi, Daniele Braga, Jacopo Troisi, Camilla Menis, Maria Lorella Giannì, Roberto Berni Canani, Lorella Paparo, Rita Nocerino, Andrea Budelli, Fabio Mosca and Maria Rescigno ()
Additional contact information
Paola Roggero: Neonatal Intensive Care Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico (IRCCS)
Nadia Liotto: Neonatal Intensive Care Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico (IRCCS)
Chiara Pozzi: Humanitas Clinical and Research Center—IRCCS
Daniele Braga: Humanitas Clinical and Research Center—IRCCS
Jacopo Troisi: Theoreo Srl
Camilla Menis: Neonatal Intensive Care Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico (IRCCS)
Maria Lorella Giannì: Neonatal Intensive Care Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico (IRCCS)
Roberto Berni Canani: Department of Translational Medical Science, University Federico II
Lorella Paparo: Department of Translational Medical Science, University Federico II
Rita Nocerino: Department of Translational Medical Science, University Federico II
Andrea Budelli: School of Engineering, Niccoló Cusano University
Fabio Mosca: Neonatal Intensive Care Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico (IRCCS)
Maria Rescigno: Humanitas Clinical and Research Center—IRCCS

Nature Communications, 2020, vol. 11, issue 1, 1-13

Abstract: 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.

Date: 2020
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DOI: 10.1038/s41467-020-16582-1

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