An Exploratory RWE Study Exploring Effects of a Goat Milk Based Young Child Formula on Health Ben… (NCT06287385) | Clinical Trial Compass
CompletedNot Applicable
An Exploratory RWE Study Exploring Effects of a Goat Milk Based Young Child Formula on Health Benefits
China121 participantsStarted 2024-03-28
Plain-language 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.
Who can participate
Age range1 Year – 2 Years
SexALL
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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;
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;
✕
What they're measuring
1
Stool characteristics
Timeframe: before and 7, 14, 21 and 28 days after administration of the investigational product