Evaluation of Feeding Intolerance in Formula-Fed Infants: A Non-Randomized, Single-Group, Multi-Center Study

Abbott Nutrition3 sites in 1 country3 target enrollmentJanuary 2014

Overview

This is a non-randomized, single-group, multi-center, two phased study to evaluate formula intolerance.

Registry

clinicaltrials.gov

Start Date

January 2014

End Date

August 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Responsible Party

Sponsor

•Inclusion Criteria for Stage 1:
•Singleton full term birth with birth weight of \> 2500g.
•Infant between 0 and 60 days of age.
•Discontinuation of medications that might affect gastrointestinal (GI) tolerance.
•Infant is exclusively formula-fed a full-lactose, intact cow milk protein-based infant formula (CMF) for less than 7 days prior to enrollment.
•Inclusion Criteria for Stage 2:
•Infant was fed according to protocol in Stage 1 of the study.
•Infant was identified as being fussy using the Intolerance Assessment Tool in Stage 1.

•Exclusion Criteria for Stage 1:
•Chromosomal or major congenital anomalies.
•Suspected or known metabolic or physical diseases affecting infant feeding and/or metabolism.
•Hospitalization, other than for delivery, prior to enrollment.
•Severe uncontrolled eczema, visible bloody stools or milk protein allergy prior to enrollment.
•More than 1 substitution of an infant formula other than full-lactose, intact cow milk formula (CMF) since birth.
•Use of a prokinetic drug within 7 days before enrollment.
•Exclusion Criteria for Stage 2:
•Infant's intolerance symptom was caused by another reason, for example known infection/illness, food allergy, or response to vaccination(s).
•Infant has immunization(s) within 3 days of enrollment in Stage 2.