Infant Nutrition
Conditions
Keywords
infant nutrition, probiotic
Brief summary
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
Interventions
DIETARY_SUPPLEMENTLfer
Probiotic bacteria originally isolated from breast milk: the strain Lactobacillus fermentum CECT5716
DIETARY_SUPPLEMENTBifido
Probiotic bacteria originally isolated from breast milk: the strain Bifidobacterium breve CECT7263
OTHERControl
Standard infant formula
Sponsors
Maimónides Biomedical Research Institute of Córdoba
Andaluz Health Service
Biosearch S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Weeks to 5 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Newborn infants at term (37-42 weeks gestational age) healthy during the first month of life, for reasons unrelated to the study, abandon breastfeeding during the first month of life. * Signature of informed parental or guardian consent.
Exclusion criteria
* Allergic to the protein in cow's milk. * Lactose intolerant. * Suffering from a serious metabolic disease. * They have experienced or are experiencing some severe gastrointestinal disease. * Receive some form of chronic medication or are receiving antibiotics at the time of capture. * Low expectation of compliance with the study protocol. * allergic to any group of antibiotics.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight gain | 12 months versus baseline | Body weight gain at 12 months (grams) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | 1,2,4,6,9 and 12 months of age | Body weight of infants at different times (kg) |
| Incidence of infections | total incidence during intervention (11 months) | Events of infections diseases during intervention period (Incidence rate) |
| Bacterial load in feces | 1,2,4,6,9 and 12 months of age | Counts of Lactobacillus, bifidobacteria, bacteroides, clostridium (CFU/g feces) |
| Regurgitation | each 2 weeks until 6 months of age and monthly until 12 months of age | 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. |
| Length | 1,2,4,6,9 and 12 months of age | Length (cm) |
| Infant colic | each 2 weeks until 6 months of age and monthly until 12 months of age | 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 |
| Flatulency | each 2 weeks until 6 months of age and monthly until 12 months of age | 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 |
| Hours of night sleep | each 2 weeks until 6 months of age and monthly until 12 months of age | 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 |
| Total hours of sleep/day | each 2 weeks until 6 months of age and monthly until 12 months of age | 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 |
| Fecal deposition | each 2 weeks until 6 months of age and monthly until 12 months of age | Measurement by score:1 = \<1 time, 2 = 1-3, 3 = 4-6, 4 = 7-10, and 5 = \>10. |
Countries
Spain
Outcome results
None listed