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| Name | Class |
|---|---|
| Danone Global Research & Innovation Center | INDUSTRY |
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In this study the effect of Infant formula with added Inulin will be compared with the effect of Infant formula without Inulin on the Bifidobacterium level in stool.
It is expected that drinking Infant formula with added Inulin will result in higher beneficial bacteria level in stool compared to an Infant formula without Inulin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group I | Experimental | Intervention group I: Powder based Infant formula with Inulin I |
|
| Intervention group II | Experimental | Intervention group II: Powder based Infant formula with Inulin II |
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| Intervention group III | Placebo Comparator | Intervention group III: Powder based Infant formula without Inulin |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Powder based infant formula | Other | Powder based infant formula with Inulin I |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between beneficial bacteria I level in stool at week 4 and week 8. | Week 4, Week 8. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between beneficial bacteria II level in stool at week 4 and week 8. | Week 4, Week 8. | |
| Difference between pH of stool at week 4 and week 8. | Week 4, Week 8. | |
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Inclusion criteria at screening:
Exclusion criteria at screening:
Exclusion criteria for intervention period:
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| Name | Affiliation | Role |
|---|---|---|
| Hanifah Oswari, dr., Sp.A(K), PhD | Research Unit of Indonesian Pediatrics Association | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Unit of Indonesian Pediatrics Association | Jakarta | Indonesia |
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| Powder based infant formula |
| Other |
Powder based infant formula with Inulin II |
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| Powder based infant formula | Other | Powder based infant formula without Inulin |
|
| Difference between stool consistency at week 4 and week 8. |
| Week 4, Week 8. |
| Difference between sIgA at week 4 and week 8. | Week 4, Week 8. |
| Difference between SCFA at week 4 and week 8. | Week 4, Week 8. |
| Safety and tolerability. | The safety and tolerability achieved by continuous recording of adverse events, including the occurrence of diarrhea and constipation. | From date of baseline visit (day 1) until the date of visit 8 (day 56) |