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| Name | Class |
|---|---|
| Harrison Clinical Research | INDUSTRY |
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The purpose of this study is to determine whether an infant formula supplemented with a new probiotic CECT7210, is effective in reducing the incidence of infections, specially the gastrointestinal ones.
This a multicenter, controlled, randomized, prospective, parallel, double-blinded study to evaluate the effect of an infant formula containing a new probiotic, Bifidobacterium longum biovar infantis CECT7210, on the incidence of diarrhea in healthy infants born at term. Infants will be randomized to take an standard infant formula or the infant formula with the probiotic CECT7210 during 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Formula | Experimental | Infant formula with a novel probiotic CECT7210 |
|
| Standard Formula | Active Comparator | Standard infant formula without probiotics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infant Formula with a novel probiotic CECT7210 | Dietary Supplement | Bottle-feeding with a new infant formula enriched with probiotic CECT7210 during the first 3 months of life. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in diarrhea incidence | Differences between diarrhea incidence amongst groups from baseline to 12th weeks. | At 4th, 8th, 12th weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in infections incidence | Differences between rate of infections or duration amongst groups. | At 4th, 8th, 12th weeks. |
| Changes in microbiota | Differences between faecal bacterial populations. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabel Polanco, Professor | Hospital Universitario La Paz | Study Chair |
| Joaquin Escribano, Professor | Hospital Sant Joan de Reus, Reus, Spain | Principal Investigator |
| Ricardo Closa, Professor | Hospital Joan XXIII de Tarragona, Tarragona, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sant Joan de Reus | Reus | Tarragona | Spain | |||
| Hospital Universitario La Paz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Closa R, Ferré N, Luque V, Gispert-Llaurado M, Ruibio-Torrents C, Polanco I, Morera M, Moreno JA, Rivero M, Escribano J. Effect of probiotic CECT7210 supplementation of infant formula in healthy infants. ESPGHAN Abstracts Book. JPGN. Vol. 60, Supplement 1, May 2015. PA-N-0038. | ||
| Result | Moreno JA, Cifuentes GC, Morera M, MartÃnez-Blach JF, Codoñer F, Genovés S, Chenoll E, Polanco I, Closa R, Escribano J, Ferré N, Luque V, Rivero M. Feeding infant formula supplemented with the probiotic bacteria bifidobacterium longum subsp.infantis CECT7210 produce beneficial changes in gastointestinal microbial communities: a metagenomic approach. ESPGHAN Abstracts Book. JPGN. Vol. 60, Supplement 1, May 2015. PO-N-0361. |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D041943 | Infant Formula |
| ID | Term |
|---|---|
| D041941 | Milk Substitutes |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Standard formula | Dietary Supplement | Standard formula without probiotics |
|
| At 4th, 8th, 12th weeks |
| Changes in Immunoglobulin A secretor (IgAs) | Differences between faecal IgAs amongst groups. | At 4th and 12th weeks |
| Tolerability of the product | To evaluate gastrointestinal tolerability of both study formulas. | At 4th, 8th and 12th weeks |
| Growth | To compare anthropometric measurements between probiotic CECT7210 formula group and standard group. | At 4th, 8th and 12th weeks |
| Madrid |
| Spain |
| Hospital Joan XXIII | Tarragona | Spain |
| D005526 |
| Food, Formulated |
| D019648 | Foods, Specialized |
| D005502 | Food |
| D007225 | Infant Food |
| D019602 | Food and Beverages |