Growth and Health Efficacy of Novel Infant Formula : A Randomized Trial (NCT07534735) | Clinical Trial Compass
RecruitingNot Applicable
Growth and Health Efficacy of Novel Infant Formula : A Randomized Trial
China120 participantsStarted 2026-05-27
Plain-language summary
Randomized, controlled study consisting of three parallel arms to investigate the effects of novel infant formula on growth, gut health, immune function, and sleep status in healthy infants and young children aged 12-18 months.
Who can participate
Age range
12 Months – 18 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:
* Healthy full-term infants (gestational age 37-42 weeks).
* Age 12-18 months (inclusive).
* Weight below the 75th percentile according to the "Growth Reference Standards for Chinese Children Under 7 Years Old".
* Has started or plans to start stage 3 formula feeding before enrollment.
* Guardian voluntarily signs written informed consent and is able to comply with all study procedures including regular visits, intervention plan, and laboratory tests.
Exclusion Criteria:
* Known allergy to milk protein or the study formula.
* Known allergic constitution or high allergy risk (parent with allergic constitution).
* Malnutrition assessed by investigator.
* Chronic infectious disease, metabolic disease, genetic disease, or any other condition affecting feeding or growth and development.
* History of preterm birth or admission to Neonatal Intensive Care Unit (NICU), excluding phototherapy for jaundice.
* Severe constipation or diagnosis of other functional gastrointestinal disorders.
* Cognitive or developmental disorders.
* Any other condition that, in the investigator's judgment, makes the infant unsuitable for participation.
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.