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: email@example.com).
Received 28 January, 2011
Accepted 17 July, 2011
This work was supported by Puleva Food S.L.
www.clinicaltrials.gov registration number: NCT012156156.
The authors report no conflicts of interest.