Long-term Safety and Efficacy of Prebiotic Enriched Infant Formula

The primary objective of the present study was to evaluate the effects of long-term supplementation of an infant formula supplemented with prebiotic inulin-type oligosaccharides on immunological-health related outcomes.

The study primarily aimed to evaluate the effects of long-term supplementation of an infant formula with a mixture of short and long chain inulin-type oligosaccharides on immunological-health related outcomes, as well as on gastrointestinal function and well-being in infants during the first year of life. Effects on infant growth, tolerance and on the composition of fecal microbiota were further objectives of this study. The study was conducted as a multicenter, randomised, double-blind, placebo-controlled study in healthy term infants. The two groups of the study are product group (standard infant formula supplemented with inulin-type fructans) and control group (non-supplemented standard infant formula).

Number of depositions per day assessed by parenteral reporting (parent's diary collected during first week of each study month throughout all study period)

Assessed via 1-3 scale with pictograms (1=hard, 2=soft/formed, 3=liquid/semi-liquid), by parenteral reporting (parent's diary collected during first week of each study month throughout all study period)

Number of vomiting and regurgitation episodes per day and presence of excessive flatulence and infantile colic, assessed by parenteral reporting (parent's diary collected during first week of each study month throughout all study period)

Calculation of z-scores of weight-for-age and length-for-age according to the World Health Organisation (WHO) standards using WHO software (WHO Antro software).

Assessment of height (cm) in supine position by using a standard measuring board at all study visits.

Assessment of total hours slept and total hours of nocturnal sleeping per day (min), by parenteral reporting (parent's diary collected during first week of each study month throughout all study period).

Assessment of crying episodes (min), by parenteral reporting (parent's diary collected during first week of each study month throughout all study period).

Inclusion Criteria: Healthy babies born between 37 - 42 weeks of gestation and with weight appropriate for gestational age (between percentiles 3 and 97) Healthy babies aged between 0 - 4 months of age Babies exclusively fed with an infant formula on enrolment into the study Exclusion Criteria: The presence of an infection at the moment of the recruitment or 1 week before recruitment The presence of important pathologies (intestinal, cardiopathy, mental retardation, etc.) Any other diseases related to the immune system (primary immunodeficiency) Parents not able to comply with the study follow up (according to physician criteria)

Rodriguez-Palmero, M.; Campoy, C.; Urraca, O.; Alonso, J.; Maldonado, J.; Varea, V.; Palencia, J.; Veereman-Wauters, G.; Neumer, F.; Rivero, M.; Vandenplas, Y. Effects of long-term supplementation with a mixture of short and long chain inulin-type oligosaccharides (2013), Annals of Nutrition and Metabolism, suppl. 1, (63), 1-1960.