Safety, growth, and support to healthy gut microbiota by an infant formula enriched with functional compounds

Elisa Civardi, Francesca Garofoli, Stefania Longo, Maria Elisa Mongini, Beatrice Grenci, Iolanda Mazzucchelli, Micol Angelini, Annamaria Castellazzi, Francesca Fasano, Alessia Grinzato, Vassilios Fanos, Andrea Budelli, Mauro Stronati

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Background & aims: Safety and growth adequacy of infant formulae enriched by functional ingredients need stringent evaluation by means of randomized controlled trials (RCTs), therefore we performed a double-blind RCT to evaluate an infant formula enriched with galacto-oligosaccharides, beta-palmitate, and acidified milk vs. a standard infant formula. Methods: Weight, length, head circumference and fecal bacteria (Bifidobacteria, BIF/Clostridia, CLO) were measured in healthy full term infants, at baseline - as before 21 days of life - at 60 and 135 days thereafter. A group of 51 neonates received the enriched formula (ENR), 59 the standard one (ST). Parents were trained to daily register gastrointestinal diseases. Results: All the infants grew homogeneously increasing the anthropometric parameters and complying with WHO and Italian standards: the mean (SD) difference in daily weight between ENR and ST groups was -0.74 (1.13) g/day, corresponding to a 90% CI of -2.62 to 1.13 g/day, well within the postulated interval of equivalence of -3.9 to +3.9 g/day. A statistical improvement in BIF concentration in the microbiota of infants fed by ENR was recorded. There was no between-group change in log10CLO, but log10BIF increase was higher at T2 vs. T0 in ENR (treatment × time interaction = 0.71, 95% CI 0.08-1.34, p = 0.028) than in ST neonates. This corresponds to estimated mean (95% CI) values of 8.37 (8.04-8.69) log10-units for ENR vs. 8.08 (7.77-8.39) log10-units for ST neonates. Gastrointestinal effects were mild and similar, with no statistical difference between two groups. Conclusion: Safety and growth ability of the enriched formula has been confirmed. A positive effect on neonatal gut microbiota, consisting of increased fecal BIF counts at T2 vs. baseline has been shown too. Nonetheless, larger RCTs are needed to estimate with greater precision the effective potential attributable to the enriched formula on neonatal microbiota, with particular reference to the mode of delivery.

Original languageEnglish
JournalClinical Nutrition
DOIs
Publication statusAccepted/In press - May 29 2015

Fingerprint

Infant Formula
Randomized Controlled Trials
Microbiota
Newborn Infant
Safety
Growth
Weights and Measures
Aptitude
Bifidobacterium
Clostridium
Gastrointestinal Diseases
Palmitates
Oligosaccharides
Milk
Parents
Head
Bacteria
Gastrointestinal Microbiome
Therapeutics

Keywords

  • Bifidobacteria
  • Formula
  • Microbiota
  • Neonate

ASJC Scopus subject areas

  • Critical Care and Intensive Care Medicine
  • Nutrition and Dietetics

Cite this

Safety, growth, and support to healthy gut microbiota by an infant formula enriched with functional compounds. / Civardi, Elisa; Garofoli, Francesca; Longo, Stefania; Mongini, Maria Elisa; Grenci, Beatrice; Mazzucchelli, Iolanda; Angelini, Micol; Castellazzi, Annamaria; Fasano, Francesca; Grinzato, Alessia; Fanos, Vassilios; Budelli, Andrea; Stronati, Mauro.

In: Clinical Nutrition, 29.05.2015.

Research output: Contribution to journalArticle

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abstract = "Background & aims: Safety and growth adequacy of infant formulae enriched by functional ingredients need stringent evaluation by means of randomized controlled trials (RCTs), therefore we performed a double-blind RCT to evaluate an infant formula enriched with galacto-oligosaccharides, beta-palmitate, and acidified milk vs. a standard infant formula. Methods: Weight, length, head circumference and fecal bacteria (Bifidobacteria, BIF/Clostridia, CLO) were measured in healthy full term infants, at baseline - as before 21 days of life - at 60 and 135 days thereafter. A group of 51 neonates received the enriched formula (ENR), 59 the standard one (ST). Parents were trained to daily register gastrointestinal diseases. Results: All the infants grew homogeneously increasing the anthropometric parameters and complying with WHO and Italian standards: the mean (SD) difference in daily weight between ENR and ST groups was -0.74 (1.13) g/day, corresponding to a 90{\%} CI of -2.62 to 1.13 g/day, well within the postulated interval of equivalence of -3.9 to +3.9 g/day. A statistical improvement in BIF concentration in the microbiota of infants fed by ENR was recorded. There was no between-group change in log10CLO, but log10BIF increase was higher at T2 vs. T0 in ENR (treatment × time interaction = 0.71, 95{\%} CI 0.08-1.34, p = 0.028) than in ST neonates. This corresponds to estimated mean (95{\%} CI) values of 8.37 (8.04-8.69) log10-units for ENR vs. 8.08 (7.77-8.39) log10-units for ST neonates. Gastrointestinal effects were mild and similar, with no statistical difference between two groups. Conclusion: Safety and growth ability of the enriched formula has been confirmed. A positive effect on neonatal gut microbiota, consisting of increased fecal BIF counts at T2 vs. baseline has been shown too. Nonetheless, larger RCTs are needed to estimate with greater precision the effective potential attributable to the enriched formula on neonatal microbiota, with particular reference to the mode of delivery.",
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AU - Garofoli, Francesca

AU - Longo, Stefania

AU - Mongini, Maria Elisa

AU - Grenci, Beatrice

AU - Mazzucchelli, Iolanda

AU - Angelini, Micol

AU - Castellazzi, Annamaria

AU - Fasano, Francesca

AU - Grinzato, Alessia

AU - Fanos, Vassilios

AU - Budelli, Andrea

AU - Stronati, Mauro

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