Behavior of Infants Fed Formula Supplemented With Prebiotics

Behavior of Infants Fed a Partially Hydrolyzed Formula Supplemented With Prebiotics

To observe the effects of partially hydrolyzed formula supplemented with oligosaccharides on symptoms of formula intolerance in healthy term infants.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Tolerance
• Intervention / Treatment: Other: Infant formula supplemented with prebiotics

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36305
      • Southeastern Pediatric Associates
  • Florida
    • Pensacola, Florida, United States, 32503
      • Pensacola Research Consultants, Inc
    • Saint Petersburg, Florida, United States, 33710
      • SCORE Physician Alliance, LLC
  • Indiana
    • Evansville, Indiana, United States, 47713
      • Deaconess Clinic, Inc.
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • Kentucky Pediatric/Adult Research
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Women's Clinic of Lincoln, PC
  • Ohio
    • Grove City, Ohio, United States, 43123
      • Aventiv Research
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Coastal Pediatric Research
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Holston Medical Group
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group
  • Texas
    • San Antonio, Texas, United States, 78229
      • Southwest Children's Research Associates, P.A.

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Subject is judged to be in good health.
• Subject is a singleton from a full-term birth with a gestational age of 37 - 42 weeks.
• Subject's birth weight was ≥ 2490 g (~5 lbs. 8 oz.).
• Infant was identified by parents as very fussy or extremely fussy.
• Infant is exclusively formula-fed at time of study entry. 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 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 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 (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance.
• Subject participates in another study that has not been approved as a concomitant study.
• Subject has been fed any formula containing human milk oligosaccharides prior to study enrollment.
• Subject has been treated with oral antibiotics within 7 days prior to study enrollment.
• Mother intends to use a combination of breast and formula feeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Infant formula supplemented with prebiotics; infant formula powder, feed ad libitum	Other: Infant formula supplemented with prebiotics; Sole source nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fussiness	Parent questionnaires	Change from baseline (3 days prior to study day 1) to within 1 day of initiation of study feeding

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fussiness	Parent Questionnaires	Baseline to Day 29
Hours of Daily Crying	Parent Questionnaires	Baseline to Day 29
Gastrointestinal Tolerance	Parent Questionnaires	Baseline to Day 29
Stool Pattern	Parent Questionnaires	Baseline to Day 29

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2016
• Primary Completion (ACTUAL): May 2, 2017
• Study Completion (ACTUAL): May 2, 2017

Study Registration Dates

• First Submitted: April 28, 2016
• First Submitted That Met QC Criteria: April 29, 2016
• First Posted (ESTIMATE): May 2, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 19, 2017
• Last Update Submitted That Met QC Criteria: June 16, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: AL20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED