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| Name | Class |
|---|---|
| Hospital Clinico Universitario San Cecilio | OTHER |
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The aim of the trial is to evaluate safety of a follow on formula supplemented with Lactobacillus salivarius CECT5713. A randomized double blind placebo controlled trial was carried out. Eighty six months old children were recruited by the department of pediatrics of Hospital Univeristario San Cecilio. Children were divided in two groups that consumed a follow on formula supplemented or not with the probiotic strain during 6 months. Fecal samples were obtained at the recruitment, at 3 months and at the end of the trial. In addition revision by the pediatrician was performed once a month and possible adverse effects were recorded both by the pediatrician and by parents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator | Children that consumed a follow on formula without Lactobacillus salivarius CECT5713 |
|
| B | Active Comparator | Children that consumed a follow on formula with Lactobacillus salivarius CECT5713 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| follow on formula without probiotics | Dietary Supplement | A follow on formula without probiotics |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse reactions | 3 months and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| growth parameters (height, length, head circumference) | 3 months and 6 months | |
| Fecal microbiota | 3 months and 6 months | |
| Fecal short chain fatty acids |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José A Maldonado, PhD, MD | Department of Pediatrics. Hospital Universitario San Cecilio | Principal Investigator |
| Mónica Olivares, PhD | Department of Nutrition and Health. Puleva Biotech. Granada | Study Chair |
| Federico Lara-Villoslada, PhD | Department of Nutrition and Helath. Puleva Biotech. Granada | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario San Cecilio | Granada | Granada | 18012 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20018483 | Derived | Maldonado J, Lara-Villoslada F, Sierra S, Sempere L, Gomez M, Rodriguez JM, Boza J, Xaus J, Olivares M. Safety and tolerance of the human milk probiotic strain Lactobacillus salivarius CECT5713 in 6-month-old children. Nutrition. 2010 Nov-Dec;26(11-12):1082-7. doi: 10.1016/j.nut.2009.08.023. Epub 2009 Dec 16. |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| follow on formula with Lactobacillus salivarius CECT5713 |
| Dietary Supplement |
follow on formula with Lactobacillus salivarius CECT5713 in a dose of 2x10E8 cfu/day |
|
| 3 months and 6 months |
| D019602 |
| Food and Beverages |