Growth, Tolerance, and Functional Biomarkers in Healthy Infants Receiving Dietary Supplements (NCT07630584) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Growth, Tolerance, and Functional Biomarkers in Healthy Infants Receiving Dietary Supplements
327 participantsStarted 2026-06-01
Plain-language summary
This is a double-blind, randomized, placebo-controlled nutritional study aimed at investigating growth, tolerance, and functional biomarkers in healthy infants receiving dietary supplements from birth to 2.5 months of age
Who can participate
Age range
14 Days – 28 Days
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
. Written informed consent has been obtained from at least one parent (or legally acceptable representative \[LAR\])
. Parent(s) / LAR(s) must be able to provide evidence of parental authority and identity
. Parent(s) / LAR(s) must understand the informed consent form and other study documents
. Parent(s) / LAR(s) are willing and able to comply with scheduled visits and the requirements of the study protocol
. Parent(s) / LAR(s) can be contacted directly by telephone throughout the study
. Parent(s) / LAR(s) must be able to temporarily store stool samples in a household freezer
. Infants may be exclusively breastfed, exclusively formula-fed, or mixed fed with both breast milk and infant formula in any proportion. Parent(s) / LAR(s) must intend to maintain the infant's current mode of feeding until the end of the study period:
. For exclusively breastfed infants: parents must intend to continue exclusive breastfeeding. As defined by the World Health Organization, exclusive breastfeeding means that the infant receives only breast milk. No other liquids or solids are given (not even water) with the exception of oral rehydration solution, or drops/syrups of vitamins, minerals, or medicines.
Exclusion criteria
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.
. Infants with conditions requiring specific infant feeding regimens other than those specified in the protocol
. Infants who have a medical condition or medical history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:
. Evidence of major congenital malformations (e.g., cleft palate, extremity malformation)
. Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis)
. Previous or ongoing antibiotic usage by the infant, except when given for prophylactic reasons (e.g., erythromycin ophthalmic ointment)
. Immunocompromised infants and those who have a central venous catheter
. History of admission to the Neonatal Intensive Care Unit, except for admission for jaundice phototherapy
. Known or suspected allergy to milk (including lactose) or soy