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

June 22, 2021 updated by: PBM Nutritionals

Effects of Addition to Infant Formula of 2-fucosyllactose (2-FL) on Growth, Fecal Bacterial Populations and Safety

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

METHODOLOGY/ STUDY DESIGN: This study is double blinded-randomized controlled trial with two arms and a reference breast fed group. The experimental variable is the composition of infant formula fed to healthy term infants for a period of 16 weeks upon entering the study as their sole source of nutrition. The formulations are a commercial control (Control, NPS-E23); and the control formula containing the human milk oligosaccharide (HMO) 2-fucosyllactose (2FL) at 1g/L (HMO, NPS-E23XA).

Infants will be enrolled on or before 14 days of age and fed a study assigned formula for 16 weeks. Weight, length and head circumference will be measured at baseline and 2, 4, 6, 8, 12 and 16 weeks of study entry. Formula volume will be recorded for a three-day period before each visit. Fecal samples will be obtained at baseline (convenience samples) and at week 16 for all subjects and analyzed for microbial populations. Buccal cheek cells of all infants, and mothers of breast fed infants, obtained by swab at week 16 will be genotyped for FUT2. Information on adverse events and new/change of medications will be collected at in person visits and by telephone interviews between in-person visits.

NUMBER OF SUBJECTS: It is estimated that approximately up to approximately 200 subjects will be enrolled in the formula groups to obtain up to approximately 65 evaluable per protocol subjects in each group. As non-randomized reference group of approximately 85 breastfed infants will be enrolled to obtain approximately 65 evaluable infants.

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • San Pedro Sula, Honduras
        • Hospital Clinica Bendana
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Alabama Clinical Therapeutics, LLC
    • Indiana
      • Evansville, Indiana, United States, 47715
        • Qualmedica Research, LLC dba Pedia Research, LLC
    • New York
      • Bronx, New York, United States, 10468
        • Advantage Clinical Trials
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • JBR Clinical Research
    • Virginia
      • Burke, Virginia, United States, 22015
        • PI-Coor Clinical Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 days to 1 month (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Commercially availabel infant formula
Infant formula
EXPERIMENTAL: Test formula with 2-FL
Infant formula
ACTIVE_COMPARATOR: Breast Fed
Infant formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Growth
Time Frame: 4 months
Growth as compared to WHO Growth Charts
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 15, 2017

Primary Completion (ACTUAL)

May 17, 2021

Study Completion (ACTUAL)

May 17, 2021

Study Registration Dates

First Submitted

April 6, 2017

First Submitted That Met QC Criteria

April 6, 2017

First Posted (ACTUAL)

April 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 24, 2021

Last Update Submitted That Met QC Criteria

June 22, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • PRG-VA-17-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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