Comparative Gastrointestinal Tolerance of Various Infant Formulas in Healthy Term Infants

Abbott Nutrition17 sites in 1 country154 target enrollmentDecember 2008

ConditionsInfant, Newborn

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Infant, Newborn
Sponsor: Abbott Nutrition
Enrollment: 154
Locations: 17
Primary Endpoint: Gastrointestinal tolerance from Study Visit 1 to Study Visit 3 at 35 days of age.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental soy-based formulas, relative to a commercially available soy-based formula.

Registry

clinicaltrials.gov

Start Date

December 2008

End Date

September 2009

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Infant is judged to be in good health.
•Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
•Infant's birth weight was \> 2490 g (\~5 lb 8 oz).
•Infant is between 0 and 8 days of age at enrollment.
•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 for the duration of the study.
•Infants using medications or home remedies, herbal preparations or rehydration/intravenous (IV) fluids that might affect GI tolerance may not be enrolled.

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.