Addition to Infant Formula of 2-fucosyllactose (2-FL) (NCT03109223) | Clinical Trial Compass
CompletedNot Applicable
Addition to Infant Formula of 2-fucosyllactose (2-FL)
United States, Honduras221 participantsStarted 2017-07-15
Plain-language summary
OBJECTIVES:
Primary:
The primary objective is to determine whether the mean weight gain over a 16-week interval starting on or before 14 days of life differs between infants fed one of two infant formulas as their sole source of nutrition: a commercial formula using a canola l fat blend (Control, E23) or the same formula containing the human milk oligosaccharide (Test (HMO) 2-fucosyllactose (2FL). Mean weight gain also will be compared to that of a concurrently enrolled reference group of exclusively breastfed infants.
Who can participate
Age range
4 Days – 36 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:
* 1\. At birth:
* Healthy, term (37-42 weeks), appropriate for gestational age 2. At the time of enrollment:
* \< 14 days post-natal age at time of enrollment, either gender
* Exclusively formula fed or breastfed upon enrollment Subject must be in general good health and free from any clinically significant disease, condition, or illness that might interfere with the study evaluations. Prior labs must be present to confirm good health.
* Formula group infants: Mother has determined to use infant formula exclusively for feeding her baby through at least 16 weeks.
* Reference breastfed infants: Mother has determined to breastfeed exclusively through at least 16 weeks Written informed consent of parent/guardian, prior to any study related procedures being performed.
Exclusion Criteria:
* 1\. Any clinically significant abnormal findings, as determined by the investigator, on the subject's medical history or physical exam during screening.
2\. Use of systemic medications by the subject that in the Investigator's opinion could impact evaluation of the subject's assessments.
3\. Discontinuation of exclusive breastfeeding by reference group (breastfed) infants.
4\. Fed with baby/solid foods on average more than once per day.
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.