Tolerance of Healthy Term Infants Fed Infant Formulas

Abbott Nutrition15 sites in 1 country270 target enrollmentSeptember 2009

ConditionsGastrointestinal Tolerance

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Gastrointestinal Tolerance
Sponsor: Abbott Nutrition
Enrollment: 270
Locations: 15
Primary Endpoint: The primary variable is Gastrointestinal tolerance.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to six experimental milk protein-based powdered infant formulas.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

January 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Nutrition

Eligibility Criteria

Inclusion Criteria

•Infant is judged to be in good health.
•Infant is a singleton from a full term birth.
•Infant's birth weight was \> 2490 g (\~5 lbs 8 oz.
•Infant is between 0 and 8 days of age at enrollment.
•Infants using medications, home remedies ,herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled.
•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, unless instructed otherwise by their healthcare professional.

Exclusion Criteria

•An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
•Infant has been treated with antibiotics.
•Infant has received probiotics.