A Randomized Double Blind Controlled Safety Trial Evaluating d-Lactic Acid Production in Healthy Infants Fed a Lactobacillus reuteri-containing Formula.

ABSTRACT:

Background

d-Lactic acidosis in infants fed lactic acid bacteria-containing products is a concern.

Methods

The primary objective of this non-inferiority trial was to compare urinary d-lactic acid concentrations during the first 28 days of life in infants fed formula containing Lactobacillus reuteri (1.2 × 10(6) colony forming units (CFU)/ml) with those fed a control formula. The non-inferiority margin was set at a two-fold increase in d-lactic acid (0.7 mmol/mol creatinine, log-transformed). Healthy term infants in Greece were enrolled between birth and 72 hours of age, and block randomized to a probiotic (N = 44) or control (N = 44) group. They were exclusively fed their formulae until 28 days of age and followed up at 7, 14, 28, 112, and 168 ± 3 days. Anthropometric measur

SUBMITTER: Papagaroufalis K 

PROVIDER: S-EPMC3999946 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature