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To evaluate the intervention effects of Bifidobacterium animalis subsp. lactis strain BLa80 in promoting growth and development (including gut microbiota and physical growth and development) of healthy infants and young children across different age groups, enhancing immune function, improving allergy incidence, and analyzing the safety of BLa80 in relation to infant growth and development, allergy incidence, and gut microbiota.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic BLa80 | Experimental | Participants receive one sachet per day containing probiotic BLa80 and maltodextrin (Day 0 to Day 84). |
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| Maltodextrin | Placebo Comparator | Participants receive one sachet per day containing maltodextrin only, serving as the placebo (Day 0 to Day 84). |
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| Blank | No Intervention | Participants in this arm will not receive any intervention or placebo. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic BLa80 | Dietary Supplement | Collect baby fecal samples, test for 16S rRNA, and analyze changes in the gut microbiota before and after supplementation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in gut microbiota | Collect patient fecal samples, test for 16S rRNA. | 84 days |
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Inclusion Criteria:
Exclusion Criteria:
Healthy infants and young children aged 0-6 months:
Infants and young children aged 6-12 months with good health
Infants and young children aged 12-36 months with good health
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vicky Achmad Ginanjar, bachelor | Contact | +62 21 7695513, 7515932 | +62 | vicky.achmad@equilab-int.com |
| Natalina Soesilawati, Dr. | Contact | +62 21 88324366 |
| Name | Affiliation | Role |
|---|---|---|
| Natalina Soesilawati, Dr. | Karya Medika II Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fakultas Kedokteran Universitas Indonesia | Jakarta Pusat | Jakarta 10430 | 10430 | Indonesia |
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| Placebo Maltodextrin | Other | Collect baby fecal samples, test for 16S rRNA, and analyze changes in the gut microbiota before and after supplementation. |
|