Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an exploratory real-world study designed to gain insight into the role of the product in terms of health benefits in toddlers, with the potential to generate hypotheses on key and other exploratory objectives.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formula fed | Experimental | Goat-milk Based Formula (Stage 3) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goat-milk Based Formula | Dietary Supplement | Provided Goat-milk Based Formula for babies 1-2 years old |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stool characteristics | Stool characteristics assessed with BITSS | before and 7, 14, 21 and 28 days after administration of the investigational product |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal symptoms | Gastrointestinal symptoms assessed with Gastrointestinal Symptom Questionnaire | before and 7, 14, 21 and 28 days after administration of the investigational product |
| Quality of life of subjects |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment includes adverse events as reported spontaneously by parents or collected by investigators. | Safety assessment includes adverse events as reported spontaneously by parents or collected by investigators. | screening until 4 weeks after product intervention |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zailing Li, PhD | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Quality of life of subjects assessed with Pediatric Quality of Life Inventory (PedsQL)
| before and 28 days after administration of the investigational product |
| Lifestyle-related immune indicators | Lifestyle-related immunity status reported by parents or medically diagnosed (indicated in the subject's medical file) | before and 28 days after administration of the investigational product |