New formula aims to boost growth in struggling infants
NCT ID NCT07549360
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a special high-energy formula called InfaCore can help undernourished infants (1-12 months old) gain weight and tolerate feeding better. About 35 babies who are not growing well or are at risk will receive the formula. The main goal is to see if their weight improves compared to when they started.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 month to 12 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Pediatrics, Faculty of Medicine, Chulalongkorn University
Bangkok, Bangkok, 10330, Thailand
More trials for these conditions
Other studies related to the condition(s) this trial covers.