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Gastrointestinal Tolerance, Growth and Safety of a Partly Fermented Formula with Specific Prebiotics in Healthy Infants: A Double-Blind, Randomized, Controlled Trial

1
Instituto Hispalense de Pediatria, 41013 Sevilla, Spain
2
Danone Nutricia Research, 3584 CT Utrecht, The Netherlands
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Servicio de Pediatría, Hospital Quiron, 08023 Barcelona, Spain
4
Department of Pediatrics, Hospital Clínico Universitario San Cecilio, 18016 Granada, Spain
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Neonatologia e Terapia Intensiva Neonatale, Ospedale Filippo Del Ponte di Varese, 21100 Varese, Italy
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Terapia Intensiva Neonatale, Ospedale dei Bambini Vittore Buzzi, ASST-FBF-Sacco, 20154 Milano, Italy
7
Intensive Therapy Unit, Hospital S. Orsola Malpighi, 40138 Bologna, Italy
8
Danone Nutricia Research, Singapore 138671, Singapore
9
Pediatrics Department, Reina Sofia University Hospital, Maimonides Institute for Biomedical research, CIBERER, 14004 Cordoba, Spain
*
Author to whom correspondence should be addressed.
Nutrients 2019, 11(7), 1530; https://doi.org/10.3390/nu11071530
Received: 7 June 2019 / Revised: 1 July 2019 / Accepted: 3 July 2019 / Published: 5 July 2019
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Abstract

This study evaluated the effect of a partly fermented infant formula (using the bacterial strains Bifidobacterium breve C50 and Streptococcus thermophilus 065) with a specific prebiotic mixture (short-chain galacto-oligosaccharides (scGOS) and long-chain fructo-oligosaccharides (lcFOS; 9:1)) on the incidence of gastrointestinal symptoms, stool characteristics, sleeping and crying behaviour, growth adequacy and safety. Two-hundred infants ≤28 days of age were assigned either to experimental infant formula containing 30% fermented formula and 0.8 g/100 mL scGOS/lcFOS or to non-fermented control infant formula without scGOS/lcFOS. A group of breastfed infants served as a reference. No relevant differences in parent-reported gastrointestinal symptoms were observed. Stool consistency was softer in the experimental versus control group with values closer to the breastfed reference group. Daily weight gain was equivalent for both formula groups (0.5 SD margins) with growth outcomes close to breastfed infants. No clinically relevant differences in adverse events were observed, apart from a lower investigator-reported prevalence of infantile colic in the experimental versus control group (1.1% vs. 8.7%; p < 0.02). Both study formulae are well-tolerated, support an adequate infant growth and are safe for use in healthy term infants. Compared to the control formula, the partly fermented formula with prebiotics induces stool consistencies closer to breastfed infants. View Full-Text
Keywords: fermented formula; scGOS/lcFOS; stool characteristics; gastrointestinal symptoms; growth adequacy; crying; sleeping fermented formula; scGOS/lcFOS; stool characteristics; gastrointestinal symptoms; growth adequacy; crying; sleeping
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Rodriguez-Herrera, A.; Mulder, K.; Bouritius, H.; Rubio, R.; Muñoz, A.; Agosti, M.; Lista, G.; Corvaglia, L.; Ludwig, T.; Abrahamse-Berkeveld, M.; Perez-Navero, J.L. Gastrointestinal Tolerance, Growth and Safety of a Partly Fermented Formula with Specific Prebiotics in Healthy Infants: A Double-Blind, Randomized, Controlled Trial. Nutrients 2019, 11, 1530.

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