Gastrointestinal Tolerance of Infant Formula

Gastrointestinal Tolerance of Formula Supplemented With Prebiotics

The study objective is to evaluate the gastrointestinal tolerance of infant formula supplemented with prebiotics.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • W.O.M.B Watching Over Mothers and Babies
  • Colorado
    • Colorado Springs, Colorado, United States, 80920
      • Clinical Research Advantage/Colorado Springs Health Partners
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Norwich Pediatric Group, PC
  • Florida
    • St. Petersburg, Florida, United States, 33710
      • SCORE Physician Alliance, LLC
  • Kentucky
    • Nicholasville, Kentucky, United States, 40356
      • Michael W. Simon, M.D., PSC
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Women's Clinic of Lincoln, PC.
  • North Carolina
    • Asheboro, North Carolina, United States, 27203
      • White Oak Family Physicians DBA Asheboro Research Associates
  • Ohio
    • Mayfield Heights,, Ohio, United States, 44124
      • Institute of Clinical Research
    • Middleburg Heights, Ohio, United States, 44130
      • The Cleveland Pediatric Research Center, LLC
  • Utah
    • Layton, Utah, United States, 84041
      • Tanner Memorial Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 week (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Infant is judged to be in good health.
• Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
• Infant's birth weight was > 2490 g (~5 lbs 8 oz.).
• Infant is between 0 and 8 days of age at enrollment.
• Parent(s) confirm their intention to feed their infant the study product (formula-fed infants) or human milk (human milk-fed infants) 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.

Exclusion Criteria:

• Adverse maternal, fetal or infant medical history that effects tolerance, growth, and/or development.
• Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect GI tolerance.
• Mother intends to use a combination of breast and formula feeding.
• Participation in another study that has not been approved as a concomitant study by AN.

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental 1 Infant Formula; Milk-based infant formula without prebiotics	Other: Experimental 1 Infant Formula; Ready to feed infant formula to be fed ad-libitum
EXPERIMENTAL: Experimental 2 Infant Formula; Milk-based infant formula with prebiotics	Other: Experimental 2 Infant Formula; Ready to feed infant formula to be fed ad-libitum
OTHER: Human Milk-Fed Reference Group; Breast fed infants	Other: Reference Group; Breast fed ad libitum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool Consistency Questionnaire	Questionnaire	Baseline to 35 Days of Age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stools per Day Questionnaire	Questionnaire	Baseline to 35 Days of Age
Feeding Spit Up Questionnaire	Questionnaire	Baseline to 35 Days of Age
Weight	Measured	Baseline to 35 Days of Age
Length	Measured	Baseline to 35 Days of Age
Head Circumference	Measured	Baseline to 35 Days of Age

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Janice Kajzer, MS, RD, LD, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ACTUAL): June 1, 2015
• Study Completion (ACTUAL): June 1, 2015

Study Registration Dates

• First Submitted: December 17, 2014
• First Submitted That Met QC Criteria: December 22, 2014
• First Posted (ESTIMATE): December 23, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): July 23, 2015
• Last Update Submitted That Met QC Criteria: July 22, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: AL14