Behavior of Infants Fed Formula Supplemented With Prebiotics

Not Applicable

Completed

• Conditions: Gastrointestinal Tolerance
• Interventions: Other: Infant formula supplemented with prebiotics

• Registration Number: NCT02757924
• Lead Sponsor: Abbott Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-28
• Study First Submitted QC: 2016-04-29
• Study Start: 2016-05
• Study First Posted: 2016-05-02
• Primary Completion: 2017-05-02
• Study Completion: 2017-05-02
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-16
• Last Update Posted: 2017-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Infant formula supplemented with prebiotics	Infant formula supplemented with prebiotics	infant formula powder, feed ad libitum

Primary Outcome Measures

Name	Time	Method
Fussiness	Change from baseline (3 days prior to study day 1) to within 1 day of initiation of study feeding	Parent questionnaires

Secondary Outcome Measures

Name	Time	Method
Fussiness	Baseline to Day 29	Parent Questionnaires
Hours of Daily Crying	Baseline to Day 29	Parent Questionnaires
Gastrointestinal Tolerance	Baseline to Day 29	Parent Questionnaires
Stool Pattern	Baseline to Day 29	Parent Questionnaires

Trial Locations

Locations (10)

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

Pensacola Research Consultants, Inc; 🇺🇸 Pensacola, Florida, United States

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

Holston Medical Group; 🇺🇸 Kingsport, Tennessee, United States

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

Deaconess Clinic, Inc.; 🇺🇸 Evansville, Indiana, United States

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

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

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

Kentucky Pediatric/Adult Research; 🇺🇸 Bardstown, Kentucky, United States