Parental Notions and Clinical Experiences About Child's Gut Comfort, Overall Satisfaction and Sen… (NCT04768933) | Clinical Trial Compass
CompletedNot Applicable
Parental Notions and Clinical Experiences About Child's Gut Comfort, Overall Satisfaction and Sense of Well-being When Consuming a New Toddler Milk
China100 participantsStarted 2020-10-11
Plain-language summary
This is a prospective, open-label, single-arm study in a real-world setting of healthy Chinese toddlers provided with new toddler milk for a total of 4 weeks (28 days).
Who can participate
Age range
12 Months – 33 Months
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
. Generally healthy toddlers born at term (37-42 weeks of gestation).
. At enrolment visit, toddler age 12-33 months.
. Birth weight ≥ 2500g and ≤ 4500g.
. No known milk intolerance / allergies to cow's milk protein.
. Habitually consuming some cow's milk or other traditional milks.
Exclusion criteria
. Toddler is currently breastfed or is consuming breast milk.
. Toddler who is experiencing growth faltering (defined as weight for length z score ≤-1.67).
. History of preterm birth
. Currently experiencing severe constipation.
. Currently diagnosed with other Functional Gastrointestinal Disorders.
. Toddlers who have known cognitive and developmental disorders.
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
Digestive tolerance
Timeframe: Baseline (week 0) and week 4 (Day 28±2)