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Pediatr Res. 2017 Apr;81(4):622-631. doi: 10.1038/pr.2016.270. Epub 2016 Dec 21.

Starter formula enriched in prebiotics and probiotics ensures normal growth of infants and promotes gut health: a randomized clinical trial.

Author information

1
Klinik für Kinder und Jugendmedizin, Klinikum Westbrandenburg GmbH, Potsdam, Germany.
2
Service de Réanimation Néonatale, Hôpital de la Croix Rousse, Lyon, France.
3
Klinik für Neonatologie, Charité Campus Virchow-Klinikum, Berlin, Germany.
4
Service de Pédiatrie 2, Hôpital Arnaud de Villeneuve, Montpellier, France.
5
Zentrum für Kinderheilkunde & Jugendmedizin, Universitätsklinikum Gießen, Germany.
6
Afdeling Kindergeneeskunde, Vrije Universiteit Medisch Centrum, Amsterdam, The Netherlands.
7
Research & Development, Nestlé Nutrition, Vevey, Switzerland.
8
Medical Nutrition, Nestle Health Science, Vevey, Switzerland.
9
Maternité Régionale Universitaire A. Pinard, CHRU, Nancy, France.

Abstract

BACKGROUND:

Prebiotics and probiotics exert beneficial effects by modulating gut microbiota and immune system. This study evaluates efficacy and safety of an infant formula containing bovine milk-derived oligosaccharides and Bifidobacterium animalis ssp lactis (B. lactis) (CNCM I-3446) on incidence of diarrhea and febrile infections during the first year of life (primary outcome).

METHODS:

Full-term infants receiving Test or Control (without bovine milk-derived oligosaccharide and B. lactis) formulae were enrolled in a multicenter, randomized, controlled, and double-blind trial with a reference breastfeeding group. .

RESULTS:

413 infants were assigned between Test (n = 206) and Control (n = 207) formula. There was no significant difference for diarrhea and febrile infections incidence between groups at 6 (odds ratio (95% confidence interval) = 0.56 (0.26-1.15), P = 0.096) and 12 mo (odds ratio = 0.66 (0.38-1.14), P = 0.119). Test formula was well tolerated, anthropometrics parameters were not significantly different between groups and aligned with WHO growth standards up to 12 mo. Data from test group showed that gut microbiota pattern, fecal IgA and stool pH were brought to be closer to those of breastfed infants.

CONCLUSION:

An infant formula enriched with bovine milk-derived oligosaccharide and B. lactis supports normal infant growth, is well tolerated and improves intestinal health markers. No differences in diarrhea and febrile infection incidence were found in the population studied.

PMID:
28002391
DOI:
10.1038/pr.2016.270
[Indexed for MEDLINE]

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