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 States221 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 range4 Days – 36 Days
SexALL
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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.