Effect of Formula on Infant Behavior

Effect of Formula Supplemented With Oligosaccharides on Infant Behavior

This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula intolerance in healthy term infants.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Tolerance
• Intervention / Treatment: Other: Infant Formula supplemented with Oligosaccharides

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Alabama Clinical Therapeutics, LLC
    • Dothan, Alabama, United States, 36305
      • Southeastern Pediatric Associates
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Watching Over Mothers and Babies
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Norwich Pediatric Group, PC
  • Florida
    • Orlando, Florida, United States, 32825
      • Florida Institute for Clinical Research, LLC
    • Saint Petersburg, Florida, United States, 33710
      • SCORE Physician Alliance, LLC
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Women's Clinic of Lincoln, PC
  • Ohio
    • Cleveland, Ohio, United States, 44124
      • Institute of Clinical Research, LLC
    • Grove City, Ohio, United States, 43123
      • Aventiv Research
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Coastal Pediatric Research
  • Texas
    • Longview, Texas, United States, 75605
      • DCOL Center for Clinical Research
    • San Antonio, Texas, United States, 78229
      • Southwest Children's Research Associates, P.A.
  • Utah
    • Layton, Utah, United States, 84041
      • Tanner Clinic

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 in good health as determined from subject's medical history by parent report
• Subject is a singleton full-term birth with a gestational age of 37 - 42 weeks
• Subject's birth weight was ≥ 2490 g (~5 lbs. 8 oz.)
• Subject is between 7 and 42 days of age
• Infant was identified by parents as very fussy or extremely fussy in the baseline tolerance evaluation
• Infant is exclusively formula-fed at time of study entry
• 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) prior to any participation in the study

Exclusion Criteria:

• An adverse maternal, fetal or subject medical history that has 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 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Infant Formula supplemented with Oligosaccharides; Ready to feed infant formula ; Feed ad libitum.	Other: Infant Formula supplemented with Oligosaccharides; 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 SD1) to within one day of initiation of study feeding (SD1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fussiness	Parent Questionnaires	Baseline to SDAY 29
Hours of daily crying	Parent Questionnaires	Baseline to SDAY 29
Gastrointestinal Tolerance	Parent Questionnaires	Baseline to SDAY 29
Stool Pattern	Parent Questionnaire	Baseline to SDAY 29

Collaborators and Investigators

• Sponsor: Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: April 13, 2016
• First Submitted That Met QC Criteria: April 18, 2016
• First Posted (Estimate): April 21, 2016

Study Record Updates

• Last Update Posted (Actual): March 30, 2017
• Last Update Submitted That Met QC Criteria: March 28, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: AL19

Plan for Individual participant data (IPD)

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