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| Name | Class |
|---|---|
| Maimónides Biomedical Research Institute of Córdoba | OTHER |
| Andaluz Health Service | OTHER_GOV |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bifido | Active Comparator | Infant formula containing Bifidobacterium breve CECT7263 |
|
| Lfer | Active Comparator | Infant formula containing Lactobacillus fermentum CECT5716 |
|
| Control | Placebo Comparator | Standard infant formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lfer | Dietary Supplement | Probiotic bacteria originally isolated from breast milk: the strain Lactobacillus fermentum CECT5716 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body weight gain | Body weight gain at 12 months (grams) | 12 months versus baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Length | Length (cm) | 1,2,4,6,9 and 12 months of age |
| Body weight | Body weight of infants at different times (kg) | 1,2,4,6,9 and 12 months of age |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Reina Sofía | Córdoba | 14004 | Spain | |||
| Servicio Andaluz de Salud |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31630683 | Derived | Maldonado J, Gil-Campos M, Maldonado-Lobon JA, Benavides MR, Flores-Rojas K, Jaldo R, Jimenez Del Barco I, Bolivar V, Valero AD, Prados E, Penalver I, Olivares M. Evaluation of the safety, tolerance and efficacy of 1-year consumption of infant formula supplemented with Lactobacillus fermentum CECT5716 Lc40 or Bifidobacterium breve CECT7263: a randomized controlled trial. BMC Pediatr. 2019 Oct 21;19(1):361. doi: 10.1186/s12887-019-1753-7. |
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| Bifido | Dietary Supplement | Probiotic bacteria originally isolated from breast milk: the strain Bifidobacterium breve CECT7263 |
|
| Control | Other | Standard infant formula |
|
| Incidence of infections | Events of infections diseases during intervention period (Incidence rate) | total incidence during intervention (11 months) |
| Bacterial load in feces | Counts of Lactobacillus, bifidobacteria, bacteroides, clostridium (CFU/g feces) | 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. | 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. | 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 | 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 | 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 | 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 | each 2 weeks until 6 months of age and monthly until 12 months of age |
| Granada |
| 10012 |
| Spain |