Feeding Intolerance in Formula-Fed Infants

Abbott

Status: Terminated

Conditions: Feeding Intolerance

Treatments: Other: Partially Hydrolyzed Infant Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT02028156

DA06

Details and patient eligibility

About

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

Enrollment: 3 patients

Sex: All

Ages: Under 60 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

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.

Trial design

3 participants in 1 patient group

Partially Hydrolyzed Infant Formula

Experimental group

Description:

Fed ad lib.

Treatment:

Other: Partially Hydrolyzed Infant Formula