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Human Milk Probiotic Lactobacillus fermentum CECT5716 Reduces the Incidence of Gastrointestinal and Upper Respiratory Tract Infections in Infants

Maldonado, José*; Cañabate, Francisco; Sempere, Luis; Vela, Francisco; Sánchez, Ana R.; Narbona, Eduardo§; López-Huertas, Eduardo||; Geerlings, Arjan; Valero, Antonio D.; Olivares, Mónica; Lara-Villoslada, Federico


In the article that appeared on page 55 of the January 2012 issue, the clinical trial registration number was provided as NCT012156156. The correct number is NCT01215656.

Journal of Pediatric Gastroenterology and Nutrition. 54(4):571, April 2012.

Journal of Pediatric Gastroenterology & Nutrition: January 2012 - Volume 54 - Issue 1 - p 55–61
doi: 10.1097/MPG.0b013e3182333f18
Original Articles: Hepatology and Nutrition

Objectives: The aim of the study was to examine the effects of a follow-on formula containing Lactobacillus fermentum CECT5716 (L fermentum) on the incidence of infections in infants between the ages of 6 and 12 months.

Patients and Methods: A randomized double-blinded controlled study including infants at the age of 6 months was conducted. Infants were assigned randomly to either follow-on formula supplemented with L fermentum plus galactooligosaccharide (experimental group, EG), or the same formula supplemented with only galactooligosaccharide (control group, CG). The main outcome was the incidence of infections for the 6-month duration of the study.

Results: The EG showed a significant 46% reduction in the incidence rate (IR) of gastrointestinal infections (EG: 0.196 ± 0.51, CG: 0.363 ± 0.53, IR ratio 0.54, 95% confidence interval [CI] 0.307–0.950, P = 0.032), 27% reduction in the incidence of upper respiratory tract infections (EG: 0.969 ± 0.96, CG: 1.330 ± 1.23, IR ratio 0.729, 95% CI 0.46–1.38, P = 0.026), and 30% reduction in the total number of infections (EG: 1.464 ± 1.15, CG: 2.077 ± 1.59, IR ratio 0.70, 95% CI 0.46–1.38, P = 0.003), at the end of the study period compared with CG.

Conclusions: Administration of a follow-on formula with L fermentum CECT5716 may be useful for the prevention of community-acquired gastrointestinal and upper respiratory infections.

*Hospital Universitario Virgen de las Nieves, Granada

Hospital Poniente de El Ejido, Carretera de Almerimar, El Ejido (Almería)

Biosearch Life SA, Granada

§Hospital Universitario San Cecilio, Granada

||Estación Experimental Zaidín, Consejo Superior Investigaciones Científicas, Granada

Department of Food Safety and Nutrition, Puleva Food S.L. Granada 18004, Spain.

Address correspondence and reprint requests to Federico Lara-Villoslada, PhD, Department of Food Safety and Nutrition, Puleva Food S.L. 66, Camino de Purchil, Granada 18004, Spain (e-mail:

Received 28 January, 2011

Accepted 17 July, 2011

This work was supported by Puleva Food S.L. registration number: NCT012156156.

The authors report no conflicts of interest.

Copyright 2012 by ESPGHAN and NASPGHAN