Addition to Infant Formula of 2-fucosyllactose (2-FL)

Completed · Not applicable

Conditions studied: Growth of Infants

In brief

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.

Key facts

Study ID

NCT03109223

Run by

PBM Nutritionals

People needed

221

Starts

2017-07-15

Expected to finish

2021-05-17

Last updated by the study team

2021-06-24

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 1. Any clinically significant abnormal findings, as determined by the investigator, on the subject's medical history or physical exam during screening.
• Use of systemic medications by the subject that in the Investigator's opinion could impact evaluation of the subject's assessments.
• Discontinuation of exclusive breastfeeding by reference group (breastfed) infants.
• Fed with baby/solid foods on average more than once per day.

Where it is running

• Alabama Clinical Therapeutics, LLC — Birmingham, Alabama, United States
• Qualmedica Research, LLC dba Pedia Research, LLC — Evansville, Indiana, United States
• Advantage Clinical Trials — The Bronx, New York, United States
• JBR Clinical Research — Salt Lake City, Utah, United States
• PI-Coor Clinical Research, LLC — Burke, Virginia, United States
• Hospital Clinica Bendana — San Pedro Sula, Honduras

Full record on ClinicalTrials.gov

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