Growth and Tolerance of Young Infants Fed Milk-Based Infant Formula With Oligosaccharides

Abbott Nutrition19 sites in 1 country189 target enrollmentJune 8, 2019

ConditionsGastro-Intestinal Tolerance

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gastro-Intestinal Tolerance
Sponsor: Abbott Nutrition
Enrollment: 189
Locations: 19
Primary Endpoint: Weight
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate growth and tolerance of healthy term infants fed an experimental milk-based infant formula with oligosaccharides compared to a control milk-based infant formula.

Registry

clinicaltrials.gov

Start Date

June 8, 2019

End Date

May 29, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Good health as determined from participant's medical history
•Singleton from a full-term birth with a gestational age of 37-42 weeks
•Birth weight was \> 2490 g (\~5 lbs. 8 oz.)
•If parent(s) of the participant elect to formula-feed the participant, parent(s) confirm the participant has not been given human milk since being discharged from the hospital following birth, and confirm their intention to feed their infant the study product as the sole source of feeding from Study Visit 1-Visit 7, unless instructed otherwise by their healthcare professional.
•If parent(s) of the participant elect to feed the infant human milk, they confirm the infant has not received any formula prior to enrollment, and confirm their intention to exclusively feed human milk from birth, and as the sole source of feeding from Study Visit 1-Visit
•Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional.
•Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or other applicable privacy regulation) authorization prior to any participation in the study.

Exclusion Criteria

•An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
•Participant is taking and plans to continue taking medications (including over the counter (OTC), such as Mylicon® for gas), prebiotics, probiotics, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance.
•Participant participates in another study that has not been approved as a concomitant study by AN.