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 range
1 Year – 2 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Stool characteristics
Timeframe: before and 7, 14, 21 and 28 days after administration of the investigational product
. 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.