Tolerability and Safety of An Infant Formula

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

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Key information

Conditions

Milk Hypersensitivity Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

1 day–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutramigen Lipil (Infant formula)

Other

Other names: Extensively hydrolyed infant formula (Nutramigen Lipil)

Primary outcomes

Infant reactivity to an extensively hydrolyzed infant formula

Time frame: 29 days

Sponsors and collaborators

Lead sponsor

Perrigo Nutritionals

Industry

Registry information

Official study title

A Multicenter, Single-blind, Randomized, Phase II Study of the Tolerability and Safety of NPS-202 in Infants With Clinically Diagnosed Cow's Milk Allergy

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2009
First posted: Jul 14, 2009
Registry last updated: Jul 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed