An Exploratory RWE Study Exploring Effects of a Goat Milk Based Young Child Formula on Health Benefits

Inclusion criteria

• Age between 1-2 years of age
• Healthy term infants, gestational ages 37~42 weeks
• Birth weight within normal range for gestational age and sex (10th to 90th percentile of the Chinese Child Growth Chart);
• Normal weight, height at screening (10th to 90th percentile of the Chinese Child Growth Chart)
• Chinese population;
• Subjects whose parents/guardians are intending to goat formula feed according to protocol during the study period;
• Informed consent from one parent or legal representative;
• Subjects whose parents/guardians are adults, have sufficient ability in Chinese to complete informed consent and other study documents;
• 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;
• Subjects whose parents/guardians can be directly contacted by telephone or WeChat throughout the study.

Exclusion criteria

• Probiotics or probiotics-supplemented products use within 4 weeks prior to enrolment;
• Goat-milk based formula or fresh goat milk use within 4 weeks prior to enrolment;
• 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.;
• Known allergy to milk products or soy product;
• Medially diagnosed disorders requiring a special diet, including but not limited to reflux esophagitis, phenylketonuria etc;
• Significant congenital abnormality or other health conditions that could affect the outcome measurements;
• Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements;
• Participation in any other studies involving investigational or marketed products concomitantly or within 4 weeks prior to entry into the study.