Healthy Children
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTGoat-milk Based Formula
Provided Goat-milk Based Formula for babies 1-2 years old
Sponsors
Danone Nutricia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 2 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age between 1-2 years of age 2. Healthy term infants, gestational ages 37\ 42 weeks 3. Birth weight within normal range for gestational age and sex (10th to 90th percentile of the Chinese Child Growth Chart); 4. Normal weight, height at screening (10th to 90th percentile of the Chinese Child Growth Chart) 5. Chinese population; 6. Subjects whose parents/guardians are intending to goat formula feed according to protocol during the study period; 7. Informed consent from one parent or legal representative; 8. Subjects whose parents/guardians are adults, have sufficient ability in Chinese to complete informed consent and other study documents; 9. Subjects whose parents/guardians are able to use smart phone with cameras; install and use a secure WeChat platform on the mobile phone during the study period; connect to the network through the mobile phone; take photos to record stool; complete questionnaires; 10. Subjects whose parents/guardians can be directly contacted by telephone or WeChat throughout the study.
Exclusion criteria
1. Probiotics or probiotics-supplemented products use within 4 weeks prior to enrolment; 2. Goat-milk based formula or fresh goat milk use within 4 weeks prior to enrolment; 3. Special infant formula use within 4 weeks prior to enrolment, including but not limited to hydrolysed infant formula, lactose-free infant formula and anti-reflux infant formula etc.; 4. Known allergy to milk products or soy product; 5. Medially diagnosed disorders requiring a special diet, including but not limited to reflux esophagitis, phenylketonuria etc; 6. Significant congenital abnormality or other health conditions that could affect the outcome measurements; 7. Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements; 8. Participation in any other studies involving investigational or marketed products concomitantly or within 4 weeks prior to entry into the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stool characteristics | before and 7, 14, 21 and 28 days after administration of the investigational product | Stool characteristics assessed with BITSS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal symptoms | before and 7, 14, 21 and 28 days after administration of the investigational product | Gastrointestinal symptoms assessed with Gastrointestinal Symptom Questionnaire |
| Quality of life of subjects | before and 28 days after administration of the investigational product | Quality of life of subjects assessed with Pediatric Quality of Life Inventory (PedsQL) |
| Lifestyle-related immune indicators | before and 28 days after administration of the investigational product | Lifestyle-related immunity status reported by parents or medically diagnosed (indicated in the subject's medical file) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety assessment includes adverse events as reported spontaneously by parents or collected by investigators. | screening until 4 weeks after product intervention | Safety assessment includes adverse events as reported spontaneously by parents or collected by investigators. |
Countries
China
Outcome results
None listed