Tolerability and Safety of An Infant Formula

Perrigo

Status: Completed

Conditions: Milk Hypersensitivity

Treatments: Other: Nutramigen Lipil (Infant formula)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00938483

CTP-0010

Details and patient eligibility

About

The purpose of this study is to evaluate an extensively hydrolyzed formula in infants with cow's milk allergy.

Enrollment: 108 patients

Sex: All

Ages: 1 day to 12 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinically diagnosed CMA
• </= 12 weeks at time of study entry
• full-term infant
• must be willing to use provided formula as sole source of nutrition
• other than CMA, infant must be otherwise healthy

Exclusion criteria

• underlying or confounding gastrointestinal abnormalities
• infants born from an addictive situation, HIV positive
• if parent/guardian is considered likely to be non-compliant with the protocol requirements

Trial design

108 participants in 2 patient groups

Extensively hydrolyzed infant formula

Experimental group

Description:

New extensively hydrolyzed formula, NPS-202

Treatment:

Other: Nutramigen Lipil (Infant formula)

Infant formula - Extensively hydrolyzed Nutramigen Lipil

Active Comparator group

Description:

Currently marketed extensively hydrolyzed formula (Nutramigen Lipil)

Treatment:

Other: Nutramigen Lipil (Infant formula)