Effect of Formula on Infant Behavior

Not Applicable

Completed

• Conditions: Gastrointestinal Tolerance
• Interventions: Other: Infant Formula supplemented with Oligosaccharides

• Registration Number: NCT02746016
• Lead Sponsor: Abbott Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-13
• Study First Submitted QC: 2016-04-18
• Study First Posted: 2016-04-21
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-28
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Infant Formula supplemented with Oligosaccharides	Infant Formula supplemented with Oligosaccharides	Ready to feed infant formula ; Feed ad libitum.

Primary Outcome Measures

Name	Time	Method
Fussiness	Change from baseline (3 days prior to SD1) to within one day of initiation of study feeding (SD1)	Parent Questionnaires

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal Tolerance	Baseline to SDAY 29	Parent Questionnaires
Fussiness	Baseline to SDAY 29	Parent Questionnaires
Hours of daily crying	Baseline to SDAY 29	Parent Questionnaires
Stool Pattern	Baseline to SDAY 29	Parent Questionnaire

Trial Locations

Locations (13)

Women's Clinic of Lincoln, PC; 🇺🇸 Lincoln, Nebraska, United States

Score Physician Alliance, LLC; 🇺🇸 Saint Petersburg, Florida, United States

Institute of Clinical Research, LLC; 🇺🇸 Cleveland, Ohio, United States

Aventiv Research; 🇺🇸 Grove City, Ohio, United States

Watching Over Mothers and Babies; 🇺🇸 Tucson, Arizona, United States

Florida Institute for Clinical Research, LLC; 🇺🇸 Orlando, Florida, United States

Coastal Pediatric Research; 🇺🇸 Charleston, South Carolina, United States

Norwich Pediatric Group, PC; 🇺🇸 Norwich, Connecticut, United States

Southeastern Pediatric Associates; 🇺🇸 Dothan, Alabama, United States

DCOL Center for Clinical Research; 🇺🇸 Longview, Texas, United States

Southwest Children's Research Associates, P.A.; 🇺🇸 San Antonio, Texas, United States

Tanner Clinic; 🇺🇸 Layton, Utah, United States

Alabama Clinical Therapeutics, LLC; 🇺🇸 Birmingham, Alabama, United States