Tolerance of Infants Fed a Hydrolysate Formula

Tolerance of Infants Fed a Hydrolysate Formula Manufactured With a New Processing Method

This is a prospective, randomized, multicenter study to assess the tolerance of infant formulas.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Tolerance
• Intervention / Treatment: Other: Hydrolysate Infant Formula 1; Other: Hydrolysate Infant Formula 2

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Watching Over Mothers and Babies
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • Springs Medical Research
  • Ohio
    • Cleveland, Ohio, United States, 44130
      • The Cleveland Pediatric Research Center, LLC
    • Mentor, Ohio, United States, 44060
      • Institute of Clinical Research, LLC
  • Tennessee
    • Memphis, Tennessee, United States, 38116
      • Midsouth Center for Clinical Research

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:

• Subject is judged to be in good health
• Singleton from a full-term birth
• Birth weight was > or = to 2490 g
• Between 0 and 14 days of age at enrollment
• Parent(s) confirm their intention to feed their infant the assigned study product as the sole source of nutrition for the duration of the study
• Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study
• Subject's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF)

Exclusion Criteria:

• An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
• Subject is taking and plans to continue medications, home remedies, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
• Subject participates in another study that has not been approved as a concomitant study
• Subject has an allergy or intolerance to any ingredient in the study product
• Subject has been treated with antibiotics within 2 weeks prior to enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hydrolysate Infant Formula 1; Ready to feed infant formula in can	Other: Hydrolysate Infant Formula 1; Feed ad lib
Experimental: Hydrolysate Infant Formula 2; Ready to feed infant formula in bottle	Other: Hydrolysate Infant Formula 2; Feed ad lib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool Characteristics	Parent completed diary	Study Day 1 - Study Day 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Formula Intake	Parent completed diary	Study Day 1 - Study Day 21
Weight	Scale	Study Day 1 - Study Day 21
Length	Length board	Study Day 1 - Study Day 21

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Courtney Allgeier, MS, RD, LD, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2018
• Primary Completion (Actual): November 23, 2018
• Study Completion (Actual): November 23, 2018

Study Registration Dates

• First Submitted: July 13, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 17, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: AL30

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