Galacto-Oligosaccharide/Polidextrose Enriched Formula Protects against Respiratory Infections in Infants at High Risk of Atopy: A Randomized Clinical Trial

富含半乳寡糖/聚葡萄糖的配方可预防过敏症高风险婴儿的呼吸道感染:一项随机临床试验

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作者:Giusy Ranucci, Vittoria Buccigrossi, Eleonora Borgia, Daniela Piacentini, Federica Visentin, Luigi Cantarutti, Paola Baiardi, Mariagrazia Felisi, Maria Immacolata Spagnuolo, Stefania Zanconato, Eugenio Baraldi, Carlo Giaquinto, Alfredo Guarino4

Background

Early nutrition affects the risk of atopy and infections through modifications of intestinal microbiota. The Prebiotics in the Prevention of Atopy (PIPA) study was a 24-month randomised, double-blind, placebo-controlled trial. It aimed to evaluate the effects of a galacto-oligosaccharide/polydextrose (GOS/PDX)-formula (PF) on atopic dermatitis (AD) and common infections in infants who were born to atopic parents and to investigate the relationship among early nutrition, gut microbiota and clinical outcomes.

Conclusion

The early administration of PF protects against RIs and mediates a species-specific modulation of the intestinal microbiota.

Methods

A total of 201 and 199 infants were randomized to receive a PF and standard formula (SF), respectively; 140 infants remained on exclusive breastfeeding (BF).

Results

The cumulative incidence of AD and its intensity and duration were not statistically different among the three groups. The number of infants with at least one episode of respiratory infection (RI) and the mean number of episodes until 48 weeks of age were significantly lower in the PF group than in the SF group. The number of patients with recurrent RIs and incidence of wheezing lower RIs until 96 weeks were lower in the PF group than the SF group, but similar to the BF group. Bifidobacteria and Clostridium cluster I colonization increased over time in the PF group but decreased in the SF and BF groups. Bifidobacteria had a protective role in RIs, whereas Clostridium cluster I was associated with atopy protection.

Trial registration

clinicaltrial.gov Identifier: NCT02116452.

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