Tolerance of Healthy Term Infants Fed Infant Formulas

Abbott Nutrition9 sites in 1 country168 target enrollmentMarch 2010

ConditionsHealthy Term Infants

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Healthy Term Infants
Sponsor: Abbott Nutrition
Enrollment: 168
Locations: 9
Primary Endpoint: GI tolerance via stool consistency
Status: Completed
Last Updated: 14 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 two experimental powdered formulas compared with a commercially available powdered formula.

Registry

clinicaltrials.gov

Start Date

March 2010

End Date

July 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Singleton full term birth in good health
•Birth weight was \> 2490 g.
•Between 0 and 8 days of age.
•Infants using medications (including OTC such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled unless both the parent and the physician agree to discontinue these agents prior to 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, unless instructed otherwise by their healthcare professional.
•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.