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The study was withdrawn due to change of the study product formulation.
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| Name | Class |
|---|---|
| Danone Global Research & Innovation Center | INDUSTRY |
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This study is initiated to investigate the effect of infant formulas with added specific prebiotic oligosaccharides on the reduction of specific potential pathogens and/or toxins.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group I | Active Comparator | Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with added prebiotic oligosaccharides mixture I |
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| Intervention Group II | Active Comparator | Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with added prebiotic oligosaccharides mixture II |
|
| Control Group | Placebo Comparator | Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with the same composition as the Investigational Formulas but without supplementation of prebiotic oligosaccharides |
|
| Reference group | No Intervention | Exclusively breast-fed infants |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regular non-hydrolysed cow's milk | Other | Regular non-hydrolysed cow's milk with added prebiotic oligosaccharides mixture I |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiota composition and its metabolic activity |
| Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal symptoms (incidence and severity) | Week 1, Week 3, Week 6, Week 8 | |
| Anthropometry | Week 1, Week 3, Week 6, Week 8 | |
| Number, type and severity of (serious) adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sungkom Jongpiputvanich, A/Prof., MD. | Chulalongkorn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Chulalongkorn Memorial Hospital | Bangkok | Thailand | ||||
| Phramongkutklao Hospital |
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| Regular non-hydrolysed cow's milk | Other | Regular non-hydrolysed cow's milk with added prebiotic oligosaccharides mixture II |
|
| Regular non-hydrolysed cow's milk | Other | Regular non-hydrolysed cow's milk with the same composition as the Investigational Formulas but without supplementation of prebiotic oligosaccharides |
|
| Week 1, Week 3, Week 6, Week 8 |
| Bangkok |
| Thailand |