Evaluation of Infants Fed an Extensively Hydrolyzed Infant Formula

Tolerance, Compliance and Growth of Infants Fed an Extensively Hydrolyzed Infant Formula With Added Human Milk Oligosaccharides

This is a single group, non-randomized, multicenter study to assess the effects of a hypoallergenic casein hydrolysate powdered infant formula on gastrointestinal (GI) tolerance, growth and compliance in an intended use infant population.

Study Overview

• Status: Completed
• Conditions: Protein Intolerance
• Intervention / Treatment: Other: Experimental Hydrolyzed Protein Infant Formula

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • College Park, Georgia, United States, 30349
      • Paramount Research Solutions
  • Kentucky
    • Nicholasville, Kentucky, United States, 40356
      • Michael W. Simon, M.D., PSC
  • Nebraska
    • Lincoln, Nebraska, United States, 68522
      • Midwest Children's Health Research Institute
  • Tennessee
    • Memphis, Tennessee, United States, 38116
      • Memphis & Shelby County Pediatric Group
  • Texas
    • Houston, Texas, United States, 77008
      • Ventavia Research Group, LLC
    • Longview, Texas, United States, 75605
      • DCOL Center for Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participant is presently consuming an extensively hydrolyzed infant formula (EHF) for persistent feeding intolerance symptoms, symptoms of suspected food protein (milk and/or soy) sensitivity, or other conditions where EHF is deemed an appropriate feeding.
• Parent(s) of infants confirm their intention not to administer prescription medications, over the counter medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect GI tolerance.
• Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
• Parent(s) confirm their intention not to administer vitamins, minerals (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study.
• Participant's parent(s) or a legally authorized representative (LAR) has voluntarily signed and dated an informed consent form (ICF) approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (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 growth, and/or development.
• Participant is receiving oral or inhaled steroids.
• Participant participates in another study that has not been approved as a concomitant study.
• Participant has an allergy or intolerance to any ingredient in the study product.
• Participant has been treated with antibiotics or other medications that in the opinion of the PI may affect growth, GI tolerance and/or development, within 2 weeks prior to enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Hydrolyzed Protein Infant Formula; hydrolyzed protein infant formula powder in cans	Other: Experimental Hydrolyzed Protein Infant Formula; fed ad libitum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight for Age	Change in weight for age z-score	Study Day 1 to Study Day 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal Tolerance	Parent completed diary questions	Study Day 1 to Study Day 60
Length	Gain measured in cm	Study Day 1 to Study Day 60
Head Circumference	Gain measured in cm	Study Day 1 to Study Day 60

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Barbara Marriage, PhD, RD, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2019
• Primary Completion (Actual): January 7, 2020
• Study Completion (Actual): January 7, 2020

Study Registration Dates

• First Submitted: March 18, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 31, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: AL32

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