Tolerance of Healthy Term Infants Fed Infant Formulas #4

Tolerance of Healthy Term Infants Fed Infant Formulas

The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental powdered formulas compared with a commercially available powdered formula.

Study Overview

• Status: Completed
• Conditions: Healthy Term Infants
• Intervention / Treatment: Other: Investigational Infant Formula A; Other: Hydrolysate based infant formula; Other: Investigational Infant Formula B

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Alabama Clinical Therapeutics, LLC
    • Dothan, Alabama, United States, 36305
      • Alabama Clinical Therapeutics, LLC
  • Florida
    • St. Petersburg, Florida, United States, 33710
      • SCORE Physician Alliance
  • Iowa
    • Coralville, Iowa, United States, 52241
      • University of Iowa
    • Dubuque, Iowa, United States, 52001
      • Medical Associates Clinic, PC
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
    • Huber Heights, Ohio, United States, 45424
      • Ohio Pediatric Research Association
    • Mayfield Heights, Ohio, United States, 44124
      • Institute of Clinical Research
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Pediatric Clinical Research Office
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • The Jackson Clinic, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 week (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Singleton full term birth in good health
• Birth weight was > 2490 g.
• Between 0 and 8 days of age.
• Infants using medications (including OTC such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled unless both the parent and the physician agree to discontinue these agents prior to enrollment.
• Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study, unless instructed otherwise by their healthcare professional.
• 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.

Exclusion Criteria:

• An adverse maternal, fetal or infant medical history and treatment with antibiotics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational infant formula A; Investigational Protein Hydrolysate formula	Other: Investigational Infant Formula A; Investigational infant formula ad lib
Active Comparator: Hydrolysate based Infant Formula	Other: Hydrolysate based infant formula; Infant formula ad lib
Experimental: Investigational Infant Formula B; Investigational Protein Hydrolysate Formula	Other: Investigational Infant Formula B; Investigational infant formula ad lib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
GI tolerance via stool consistency	28 days

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Marlene Borschel, PhD, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: June 28, 2010
• First Submitted That Met QC Criteria: June 30, 2010
• First Posted (Estimate): July 1, 2010

Study Record Updates

• Last Update Posted (Estimate): November 1, 2011
• Last Update Submitted That Met QC Criteria: October 31, 2011
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: AK75