Abstract

BackgroundAdequate nutrition is essential during pregnancy and lactation to provide sufficient energy and nutrients to meet the nutritional requirements of the mother, fetus and infant. The primary objective of this study was to assess the effect of a maternal nutritional supplement enriched with probiotics during pregnancy and early lactation on the incidence of infant diarrhea.MethodsHealthy, pregnant (24–28 weeks gestation) women were randomized 1:1:1 to receive either no supplement or two servings per day of an oral supplement (140 kcal/serving) providing 7.9 g protein, multivitamin/minerals, and enriched or not with the probiotics Lactobacillus rhamnosus and Bifidobacterium lactis, from the third trimester of pregnancy until at least 2 months post-delivery. Incidence of infant diarrhea until 12 months post-delivery was analyzed by Poisson regression. The effect on maternal health, fetal growth, and infant growth and morbidity were also evaluated and analyzed by ANOVA.ResultsA total of 208 mother/infant pairs were included in the analysis. No significant difference in the incidence of infant diarrhea was observed between the three study groups. The mean maternal weight gains at delivery were similar among groups, despite an increase in caloric intake in the supplemented groups. No statistically significant differences between groups were observed in incidence of pregnancy-related or fetal adverse outcomes. Mean weight-, length-, BMI- and head circumference-for-age z-scores were below the WHO median value for all groups. Post-hoc analysis to compare the effect of the combined supplement groups versus the no supplement group on infant growth parameters showed, at 12 months, that the combined supplemented group had gained statistically significant more weight (8.97 vs. 8.61 kg, p = 0.001) and height (74.2 vs. 73.4 cm, p = 0.031), and had a higher weight-for-age z-score (− 0.62 vs. -0.88, p = 0.045) than the no supplement group.ConclusionsMaternal nutritional supplement with or without probiotics given during late pregnancy and early lactation was well tolerated and safe. Even though no difference in incidence of infant diarrhea was observed between the three groups, the analysis of the combined supplemented groups showed beneficial effects of maternal supplementation on infant weight and length gains at 12 months.Trial registrationClinicalTrial.gov: NCT01073033. Registered 17.02.2010.

Highlights

  • Adequate nutrition is essential during pregnancy and lactation to provide sufficient energy and nutrients to meet the nutritional requirements of the mother, fetus and infant

  • The primary objective of the trial was to examine the effect of an oral nutritional supplement containing a mix of probiotics Lactobacillus rhamnosus and Bifidobacterium lactis, taken during pregnancy and up to minimally 2 months post-delivery on the incidence of diarrhea in infants from birth to one year of age

  • The results described are based on the full analysis set (FAS) population

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Summary

Introduction

Adequate nutrition is essential during pregnancy and lactation to provide sufficient energy and nutrients to meet the nutritional requirements of the mother, fetus and infant. The recommended intake during pregnancy for several nutrients such as iron, folate and vitamin B6 are up to 50% higher than those for a non-pregnant state, which could prove challenging [3]. Other micronutrients (i.e., vitamin B12, iron, and folate) are commonly deficient worldwide [3] This is of particular importance considering that maternal undernutrition can lead to miscarriage and major developmental issues such as intrauterine growth restriction, low birth weight and premature births [4, 5]. Maternal nutrition, especially micronutrient intake, is an important determinant of health as an adult. This has been shown to have an impact on the development of cardiovascular diseases and obesity [7, 8]

Objectives
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