» Articles » PMID: 29494489

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

Abstract

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.

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.

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

Trial Registration: clinicaltrial.gov Identifier: NCT02116452.

Citing Articles

Effects of Infant Formula Supplemented With Prebiotics on the Gut Microbiome, Gut Environment, Growth Parameters, and Safety and Tolerance: A Systematic Review and Meta-Analysis.

Kebbe M, Leung K, Perrett B, Reimer R, Adamo K, Redman L Nutr Rev. 2025; 83(3):422-447.

PMID: 39832301 PMC: 11819492. DOI: 10.1093/nutrit/nuae184.


Role of Human Milk Microbiota in Infant Neurodevelopment: Mechanisms and Clinical Implications.

Biagioli V, Sortino V, Falsaperla R, Striano P Children (Basel). 2025; 11(12.

PMID: 39767905 PMC: 11674883. DOI: 10.3390/children11121476.


Philippine guidelines on the dietary primary prevention of allergic diseases in children.

Casis Hao R, Genuino M, Tan-Lim C, Capulong R, Castor M, Francisco P Asia Pac Allergy. 2024; 14(4):191-213.

PMID: 39624442 PMC: 11608615. DOI: 10.5415/apallergy.0000000000000158.


Probiotics and Prebiotics Intervention in Respiratory and Digestive Infections Linked to Covid-19.

Amrouche T, Lammi S, Drider D Probiotics Antimicrob Proteins. 2024; .

PMID: 39614066 DOI: 10.1007/s12602-024-10404-2.


Vitamin D and prebiotics for intestinal health in cystic fibrosis: Rationale and design for a randomized, placebo-controlled, double-blind, 2 x 2 trial of administration of prebiotics and cholecalciferol (vitamin D) (Pre-D trial) in adults with....

Sivapiromrat A, Suppakitjanusant P, Wang Y, Hu C, Binongo J, Hunt W Contemp Clin Trials Commun. 2024; 38:101278.

PMID: 38435430 PMC: 10904905. DOI: 10.1016/j.conctc.2024.101278.


References
1.
Kummeling I, Thijs C, Penders J, Snijders B, Stelma F, Reimerink J . Etiology of atopy in infancy: the KOALA Birth Cohort Study. Pediatr Allergy Immunol. 2005; 16(8):679-84. DOI: 10.1111/j.1399-3038.2005.00333.x. View

2.
Gidaris D, Urquhart D, Anthracopoulos M . 'They said it was bronchiolitis; is it going to turn into asthma doctor?'. Respirology. 2014; 19(8):1158-64. DOI: 10.1111/resp.12371. View

3.
Kusel M, de Klerk N, Holt P, Landau L, Sly P . Occurrence and management of acute respiratory illnesses in early childhood. J Paediatr Child Health. 2007; 43(3):139-46. DOI: 10.1111/j.1440-1754.2007.01033.x. View

4.
Harmsen H, Raangs G, Wagendorp A, Klijn N, Bindels J, Welling G . Analysis of intestinal flora development in breast-fed and formula-fed infants by using molecular identification and detection methods. J Pediatr Gastroenterol Nutr. 2000; 30(1):61-7. DOI: 10.1097/00005176-200001000-00019. View

5.
Penders J, Stobberingh E, van den Brandt P, Thijs C . The role of the intestinal microbiota in the development of atopic disorders. Allergy. 2007; 62(11):1223-36. DOI: 10.1111/j.1398-9995.2007.01462.x. View