Growth and Tolerance of Infants Fed Milk-Based Infant Formula

Growth and Tolerance of Young Infants Fed Milk-Based Infant Formula With Oligosaccharides

The purpose of this study is to evaluate growth and tolerance of healthy term infants fed an experimental milk-based infant formula with oligosaccharides compared to a control milk-based infant formula.

Study Overview

• Status: Completed
• Conditions: Gastro-Intestinal Tolerance
• Intervention / Treatment: Other: Control Infant Formula; Other: Experimental Infant Formula; Other: Reference Group

• Study Type: Interventional
• Enrollment (Actual): 189
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Watching Over Mothers & Babies
  • California
    • Sacramento, California, United States, 95815
      • Pediatric Medical Associates
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Norwich Pediatric Group, P.C.
  • Florida
    • Miami, Florida, United States, 33165
      • Phoenix Medical Research LLC
    • Orlando, Florida, United States, 32829
      • University Clinical Research-Deland, LLC a/b/a Accel Clinical Research
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Clinical Research Prime
  • Indiana
    • Evansville, Indiana, United States, 47725
      • Deaconess Clinic, Inc.
  • Kentucky
    • Nicholasville, Kentucky, United States, 40356
      • Michael W. Simon, M.D., PSC
    • Owensboro, Kentucky, United States, 42303
      • Springs Medical Research
  • Ohio
    • Mentor, Ohio, United States, 44060
      • Institute of Clinical Research, LLC
    • Middleburg Heights, Ohio, United States, 44130
      • The Cleveland Pediatric Research Center, LLC
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group
    • Memphis, Tennessee, United States, 38116
      • Midsouth Center for Clinical Research
  • Texas
    • Austin, Texas, United States, 78726
      • ARC Clinical Research at Wilson Parke
    • Fort Worth, Texas, United States, 76104
      • Ventavia Research Group, LLC
    • Houston, Texas, United States, 77008
      • Ventavia Research Group
    • Keller, Texas, United States, 76248
      • Ventavia Research Group, LLC 3078
    • Pearland, Texas, United States, 77584
      • Kagan Pediatrics - HD Research Corporation
    • Plano, Texas, United States, 75093
      • Plano Pediatrics - ACRC Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 weeks (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Good health as determined from participant's medical history
• Singleton from a full-term birth with a gestational age of 37-42 weeks
• Birth weight was > 2490 g (~5 lbs. 8 oz.)
• If parent(s) of the participant elect to formula-feed the participant, parent(s) confirm the participant has not been given human milk since being discharged from the hospital following birth, and confirm their intention to feed their infant the study product as the sole source of feeding from Study Visit 1-Visit 7, unless instructed otherwise by their healthcare professional.
• If parent(s) of the participant elect to feed the infant human milk, they confirm the infant has not received any formula prior to enrollment, and confirm their intention to exclusively feed human milk from birth, and as the sole source of feeding from Study Visit 1-Visit 7.
• Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional.
• Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or other applicable privacy regulation) authorization prior to any participation in the study.

Exclusion Criteria:

• An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
• Participant is taking and plans to continue taking medications (including over the counter (OTC), such as Mylicon® for gas), prebiotics, probiotics, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance.
• Participant participates in another study that has not been approved as a concomitant study by AN.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control Infant Formula; Milk-based infant formula	Other: Control Infant Formula; Ready to feed infant formula, feed ad libitum
EXPERIMENTAL: Experimental Infant Formula; Milk-based Infant Formula with oligosaccharides	Other: Experimental Infant Formula; Ready to feed infant formula, feed ad libitum
OTHER: Reference Group; Human-milk fed	Other: Reference Group; Human milk, breast feeding ad libitum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Weight gain per day	Day of life 14 - 119

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool Characteristics	Parent completed diary	Study Day 1 to Day of life 119
Formula Tolerance	Parent completed diary	Study Day 1 to Day of life 119
Length	Length gain per day	Study Day 1 to Day of life 119
Head Circumference (HC)	HC gain per day	Study Day 1 to Day of life 119
Illness Incidence	Parent reported incidence of illness	Study Day 1 to Day of life 119

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool Sample	Microbiota characterization	Study Day 1 to Day of life 119

Collaborators and Investigators

• Sponsor: Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 8, 2019
• Primary Completion (ACTUAL): May 29, 2020
• Study Completion (ACTUAL): May 29, 2020

Study Registration Dates

• First Submitted: May 27, 2019
• First Submitted That Met QC Criteria: May 27, 2019
• First Posted (ACTUAL): May 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 21, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: AL29A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No