Efficacy of a Dietary Supplement in Infants (NCT07341477) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy of a Dietary Supplement in Infants
172 participantsStarted 2026-06
Plain-language summary
This is a double-blind, randomized, placebo-controlled nutritional study of healthy term infants. The primary objective of the trial is to demonstrate a favorable change in fecal microbiome composition in infants receiving a dietary supplement compared to infants receiving a placebo supplement.
Who can participate
Age range
19 Weeks – 21 Weeks
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 including infant blood collection
. 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
. Parent(s) / LAR(s) of formula-fed infants (either exclusively or mixed-fed) must have previously and independently decided to use formula and their infant must be consuming and tolerating a standard cow's milk infant formula not containing probiotics at the time of enrollment
. Infant must be healthy based on medical history and physical examination
Exclusion criteria
. Infants with conditions requiring specific infant feeding regimens other than those specified in the protocol
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 receiving solid foods or liquids other than breastmilk or infant formula within 4 weeks prior to enrollment
. 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)
. 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