Tolerability and Safety of An Infant Formula

N/ACompletedNCT00938483

Perrigo Nutritionals108 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

108

Conditions

Milk Hypersensitivity

Interventions

Nutramigen Lipil (Infant formula)OTHER

Eligibility

Sex: ALLMin age: 1 DayMax age: 12 Weeks

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Infant reactivity to an extensively hydrolyzed infant formula

Time frame: 29 days

Data from ClinicalTrials.gov

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