The aim of this trial is to test the efficacy of an infant formula containing synbiotics on the prevention of gastro-intestinal infections.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
477
Hôpital de la Croix Rousse, Service de réanimation néonatale
Lyon, France
Hôpital Arnaud de Villeneuve, Service de pédiatrie 2
Montpellier, France
Maternité régionale de Nancy, Service de Néonatologie
Nancy, France
Charité Campus Virchow-Klinikum, Klinik für Geburtsmedizin
Diarrhea and all infections with fever
Mean event rate of diarrhea and all infections with fever per child over 6 months and 1 year
Time frame: over 6 months and 1 year
Morbidity
Frequency of episodes of morbidity (adverse events), especially mean event rate of respiratory illnesses per child over 6 months and 1 year
Time frame: over 6 months and 1 year
Anthropometry
Anthropometry (weight (kg), length (cm), head circumference (cm) and skin fold)
Time frame: until 1 year
Digestive tolerance
Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic)
Time frame: until 1 year
Stool characteristics
* Stool bacterial populations (Bifidobacteria, Lactobacilli Species, Clostridium, Bacteroides, Staphylococci epidermitis, presence or absence of B. lactis) * Stool pH * Stool and saliva S.IgA * Stool Alpha 1-antitrypsine as infection/inflammation marker
Time frame: at 3 and 6 months
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Berlin, Germany
Universitätsklinikum Gießen und Marburg, Zentrum für Kinderheilkunde und Jugendmedizin
Giessen, Germany
Klinikum Ernest von Bergmann, Klinik für Kinder- und Jugendmedizin
Potsdam, Germany
Vrije Universiteit Medisch Centrum, Afdeling Kindergeneeskunde
Amsterdam, Netherlands