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| Name | Class |
|---|---|
| PT Nutricia Indonesia Sejahtera | UNKNOWN |
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This study investigates the effects of follow-on formula in infants aged 6-9 months over a 12-week period. After parents give consent, their baby's feeding habits, stool characteristics, and any illnesses or medication use will be recorded. Infants will be randomly assigned to receive either the test or control product. Growth and health data will be collected during study visits.
Parents will collect stool samples and complete diaries to help researchers better understand the baby's digestion and overall health. A follow-up phone call will be made to check on the baby's well-being after the study ends.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| test product | Experimental | Group that receives follow-on formula with synbiotics |
|
| control product | Active Comparator | Group that receives regular follow-on formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test: Follow-on formula with synbiotics | Other | Intervention description: both products are nutritionally complete follow-on formulas |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bifidobacteria proportions | The mean change from baseline in the proportion of faecal Bifidobacterium at 12 weeks postbaseline | Baseline and 12 weeks postbaseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danone Global Research & Innovation Center | Contact | +31 30 2095 000 | register.clinicalresearchnutricia@danone.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DPS_RSUP Prof. Dr. I.G.N.G. Ngoerah | Denpasar | Bali | Indonesia |
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| ID | Term |
|---|---|
| D058616 | Synbiotics |
| ID | Term |
|---|---|
| D056692 | Prebiotics |
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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| Control: Regular follow-on formula | Other | Intervention description: both products are nutritionally complete follow-on formulas |
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| SBY_RSUD Dr. Soetomo | Surabaya | East Java | Indonesia |
|
| D010829 |
| Physiological Phenomena |
| D019936 | Probiotics |
| D019602 | Food and Beverages |