Close
Help




JOURNAL

Nutrition and Metabolic Insights

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

Submit a Paper


Nutrition and Metabolic Insights 2014:7 19-27

Original Research

Published on 22 Apr 2014

DOI: 10.4137/NMI.S14113


Further metadata provided in PDF



Sign up for email alerts to receive notifications of new articles published in Nutrition and Metabolic Insights

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 x 10⁶ 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 measurements were taken at each visit and tolerance recorded until 112 days. Urine was collected before study formula intake and at all visits up to 112 days and blood at 14 days.

Results: D-Lactic acid concentration in the probiotic group was below the non-inferiority margin at 28 days: treatment effect -0.03 (95% confidence interval [CI]: [-0.48 to 0.41]) mmol/mol creatinine but was above the non-inferiority margin at 7 and 14 days—treatment effect 0.50 (95% CI: [0.05–0.96]) mmol/mol creatinine and 0.45 (95% CI: [0.00–0.90]) mmol/mol creatinine, respectively. Blood acid excess and pH, anthropometry, tolerance, and adverse events (AEs) were not significantly different between groups.

Conclusion: Intake of L. reuteri-containing formula was safe and did not cause an increase in D-lactic acid beyond two weeks.

Trial Registration: ClinicalTrials.gov NCT01119170.



Downloads

PDF  (999.22 KB PDF FORMAT)

RIS citation   (ENDNOTE, REFERENCE MANAGER, PROCITE, REFWORKS)

BibTex citation   (BIBDESK, LATEX)

XML




Quick Links


New article and journal news notification services