Leveraging Optimal Tolerance in Undernourished Infants to Support Growth (NCT07549360) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Leveraging Optimal Tolerance in Undernourished Infants to Support Growth
Thailand35 participantsStarted 2026-05-15
Plain-language summary
The goal of this study is to learn if InfaCore (IC) an energy and nutrient dense formulation (ENDF) can improve growth and tolerance in infants with or at risk of growth faltering when fed IC.
Who can participate
Age range
1 Month – 12 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:
* Infants aged from 1 month to \</=12 months of age
* Infants taking at least 50% of daily intake from infant formula
* Diagnosis of FG (a fall in WAZ of ≥1.0 SD over 1 month or more - not including the first 2 weeks after birth) or risk of FG (static weight for \>/= 1 month)
* Infants \>/=37 weeks gestation at time of recruitment
* Parent/ legal guardian willing to provide written informed consent
Exclusion Criteria:
* Exclusively Breastfed infants
* Infants with other medical problems that might independently affect intake (oral or otherwise) or who have specific nutrient needs not met by IC e.g. some gastrointestinal malformations, some renal and liver conditions, inborn errors of metabolism, galactosemia
* Infants on total parenteral nutrition
* Infants with cow milk protein allergy
* Infants with soy allergy
* Infants who participated in other studies within 2 weeks prior to recruitment
* Situations where the investigator has concerns about the willingness or ability of the parents/caregivers to comply with protocol requirements
* Infants who are on a vegan diet
* Infants who are allergic to fish
* Infants born preterm \<37 weeks gestation
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.