A randomized double blinded controlled study including infants at the age of 1 month . Infants are assigned randomly to either infant formula supplemented with B. breve CECT7263 or L.fermentum CECT5716 (Probiotic groups), or the same formula without the probiotic strain (Control group). The primary outcome of the study is the body weight gain of infants. Secondary outcomes are incidence of infections, symptoms related with intestinal function, and fecal microbiota
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
236
Hospital Reina Sofía
Córdoba, Spain
Servicio Andaluz de Salud
Granada, Spain
Body weight gain
Body weight gain at 12 months (grams)
Time frame: 12 months versus baseline
Length
Length (cm)
Time frame: 1,2,4,6,9 and 12 months of age
Body weight
Body weight of infants at different times (kg)
Time frame: 1,2,4,6,9 and 12 months of age
Incidence of infections
Events of infections diseases during intervention period (Incidence rate)
Time frame: total incidence during intervention (11 months)
Bacterial load in feces
Counts of Lactobacillus, bifidobacteria, bacteroides, clostridium (CFU/g feces)
Time frame: 1,2,4,6,9 and 12 months of age
Regurgitation
Measurement by score: 1 = not at all, 2 = regurgitation of small amounts during or shortly after feeding, 3 = larger regurgitation during or shortly after feeding, 4 = minor vomiting with time-lag to prior feeding, and 5 = severe vomiting with considerable loss of fluid.
Time frame: each 2 weeks until 6 months of age and monthly until 12 months of age
Fecal deposition
Measurement by score:1 = \<1 time, 2 = 1-3, 3 = 4-6, 4 = 7-10, and 5 = \>10.
Time frame: each 2 weeks until 6 months of age and monthly until 12 months of age
Infant colic
Average crying hours per day during the last two days of each period of measurement which is each 2 weeks until 6 months of age and monthly until 12 months of age. Score: no crying; \< 3 hours/day; 3-6 hours/day; 6-12 hours/day; \> 12 hours/day
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: each 2 weeks until 6 months of age and monthly until 12 months of age
Flatulency
Average of duration of flatulence episodes (hours per day) during the last two days of each period of measurement which is each 2 weeks until 6 months of age and monthly until 12 months of age.Measurement by the score:no flatulency; \< 3 hours/day; 3-6 hours/day; 6-12 hours/day; \> 12 hours/day
Time frame: each 2 weeks until 6 months of age and monthly until 12 months of age
Hours of night sleep
Average of time of night sleep (hours per day) during the last two days of each period of measurement which is each 2 weeks until 6 months of age and monthly until 12 months of age.Measurement by the score: \< 4 hours ; 4-6 hours; 6-9 hours; 9-12 hours; \> 12 hours
Time frame: each 2 weeks until 6 months of age and monthly until 12 months of age
Total hours of sleep/day
Average of total time of sleep (hours per day) during the last two days of each period of measurement which is each 2 weeks until 6 months of age and monthly until 12 months of age.Measurement by the score: \< 11 hours; 11-14 hours; 14-17 hours; 17-20 hours; \> 20 hours
Time frame: each 2 weeks until 6 months of age and monthly until 12 months of age