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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03109223
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
PBM Nutritionals

Brief 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.


Condition or disease Intervention/treatment Phase
Growth of Infants Other: sole source nutrition Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double blind
Primary Purpose: Other
Official Title: Effects of Addition to Infant Formula of 2-fucosyllactose (2-FL) on Growth, Fecal Bacterial Populations and Safety
Actual Study Start Date : July 15, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Commercially availabel infant formula Other: sole source nutrition
Infant formula

Experimental: Test formula with 2-FL Other: sole source nutrition
Infant formula

Active Comparator: Breast Fed Other: sole source nutrition
Infant formula




Primary Outcome Measures :
  1. Growth [ Time Frame: 4 months ]
    Growth as compared to WHO Growth Charts



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 36 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109223


Locations
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United States, Alabama
Alabama Clinical Therapeutics, LLC Recruiting
Birmingham, Alabama, United States, 35205
Contact: Max Hale, MD    205-933-8522    rosanne.fowler@actstudy.net   
United States, Indiana
Qualmedica Research, LLC dba Pedia Research, LLC Recruiting
Evansville, Indiana, United States, 47715
Contact: David Brougher, MD    812-604-0088    jackie.rohner@qualmedicaresearch.com   
United States, New York
Advantage Clinical Trials Recruiting
Bronx, New York, United States, 10468
Contact: Giancarlo Guido, MD    917-962-0234    mrodriguez@advantageclinicaltrials.com   
United States, Utah
JBR Clinical Research Recruiting
Salt Lake City, Utah, United States, 84107
Contact: Gary W Schlichter, MD    801-261-2000 ext 317    lpaustenbaugh@jbrutah.com   
United States, Virginia
PI-Coor Clinical Research, LLC Recruiting
Burke, Virginia, United States, 22015
Contact: William Rees, MD    703-426-0800    sarahmocres@gmail.com   
Honduras
Hospital Clinica Bendana Recruiting
San Pedro Sula, Honduras
Contact: Nelly Paz, MD    305-227-0400    idavie@intldermresearch.com   
Sponsors and Collaborators
PBM Nutritionals
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Responsible Party: PBM Nutritionals
ClinicalTrials.gov Identifier: NCT03109223    
Other Study ID Numbers: PRG-VA-17-001
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No