Tolerability and Safety of An Infant Formula

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00938483

Enrollment

108

Registered

2009-07-14

Start date

2007-08-31

Completion date

2009-01-31

Last updated

2009-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Milk Hypersensitivity

Keywords

infant formula, cow's milk allergy

Brief summary

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

Interventions

OTHERNutramigen Lipil (Infant formula)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Caregiver)

Eligibility

Sex/Gender

ALL

Age

1 Days to 12 Weeks

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

Design outcomes

Primary

Measure	Time frame
Infant reactivity to an extensively hydrolyzed infant formula	29 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026