Lactobacillus fermentum CECT 5716 is safe and well tolerated in infants of 1-6 months of age: a randomized controlled trial
| Autor: | Eduardo López-Huertas, Arjan Geerlings, Mª Dolores Linares, Mónica Olivares, Kristin L. Ritzenthaler, Mercedes Gil-Campos, Victor Navas, Federico Lara-Villoslada, Inés Roncero, Jose A. Maldonado-Lobón, José Maldonado, Antonio Valero, Regina Berwind, Miguel Ángel López, Lluis Sempere, Carlos Sierra, Julio Romero, Mª Victoria Rodriguez-Benítez |
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| Rok vydání: | 2011 |
| Předmět: |
Male
Pediatrics medicine.medical_specialty Limosilactobacillus fermentum Lactobacillus fermentum medicine.medical_treatment Breast milk Weight Gain law.invention Probiotic Feces Randomized controlled trial law Internal medicine medicine Humans Infant Nutritional Physiological Phenomena Pharmacology biology Anthropometry Milk Human business.industry Incidence (epidemiology) Prebiotic Probiotics Infant Newborn Infant biology.organism_classification Infant Formula Infant formula Female medicine.symptom business Weight gain |
| Zdroj: | Pharmacological research. 65(2) |
| ISSN: | 1096-1186 |
| Popis: | The objective of the study was to evaluate the safety and tolerance of an infant formula supplemented with Lactobacillus fermentum CECT5716, a probiotic strain isolated from breast milk, in infants of 1–6 months of age. A randomized double blinded controlled study including healthy infants was conducted. One month aged infants received a prebiotic infant formula supplemented with L. fermentum (experimental group) or the same formula without the probiotic strain (control group) for 5 months. The primary outcome of the study was average daily weight gain between baseline and 4 months of age. Secondary outcomes were other anthropometric data (length and head circumference), formula consumption, and tolerance. Incidence of infections was also recorded by pediatricians. No significant differences in weight gain were observed between both groups, neither at 4 months of age (29.0 ± 7.8 vs 28.9 ± 5.7 g/day) nor at 6 months (25.1 ± 6.1 vs 24.7 ± 5.2 g/day). There were no statistically significant differences in the consumption of the formulae or symptoms related to the tolerance of the formula. The incidence rate of gastrointestinal infections in infants of the control group was 3 times higher than in the probiotic group (p = 0.018). Therefore, consumption of a prebiotic infant formula enriched with the human milk probiotic strain L. fermentum CECT5716 from 1 to 6 months of life is well tolerated and safe. Furthermore, the consumption of this formula may improve the health of the infants by reducing the incidence of gastrointestinal infections. |
| Databáze: | OpenAIRE |
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