Alternate Formula Feedings in Formula Intolerant Infants

Abbott

Status: Completed

Conditions: Gastrointestinal Tolerance

Treatments: Other: Infant Formula 2; Other: Infant Formula 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT02456805

AH23

Details and patient eligibility

About

This study assessed tolerance improvement of a formula change in healthy term infants with perceived intolerance to their current milk-based formula feeding.

Enrollment: 113 patients

Sex: All

Ages: 2 to 9 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants formula-fed exclusively and experiencing symptoms of cow's milk formula intolerance.
• Infants whose physicians had made a recommendation that the parents change the infant's feeding.
• Full term infants at birth with a gestational age of 37 to 42 weeks.
• Infants 2- 9 weeks of age at study entry with birth weights greater than 2500 grams.

Exclusion criteria

• Infants with a maternal medical history which had adverse effects on the fetus, such as diabetes, tuberculosis, perinatal infections, or substance abuse.
• Infants with evidence of cardiac, respiratory, gastrointestinal, hematological, or metabolic disease.

Trial design

113 participants in 2 patient groups

Infant Formula 1

Active Comparator group

Description:

A standard commercial milk-based infant formula

Treatment:

Other: Infant Formula 1

Infant Formula 2

Experimental group

Description:

A standard commercial soy-based infant formula.

Treatment:

Other: Infant Formula 2