NCT00938483

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 14, 2009

Completed
Last Updated

July 15, 2009

Status Verified

July 1, 2009

Enrollment Period

1.1 years

First QC Date

July 7, 2009

Last Update Submit

July 14, 2009

Conditions

Milk Hypersensitivity

Keywords

infant formulacow's milk allergy

Outcome Measures

Primary Outcomes (1)

  • Infant reactivity to an extensively hydrolyzed infant formula

    29 days

Study Arms (2)

Extensively hydrolyzed infant formula

EXPERIMENTAL

New extensively hydrolyzed formula, NPS-202

Other: Nutramigen Lipil (Infant formula)

Infant formula - Extensively hydrolyzed Nutramigen Lipil

ACTIVE COMPARATOR

Currently marketed extensively hydrolyzed formula (Nutramigen Lipil)

Other: Nutramigen Lipil (Infant formula)

Interventions

Nutramigen Lipil (Infant formula)OTHER
Also known as: Extensively hydrolyed infant formula (Nutramigen Lipil)
Extensively hydrolyzed infant formulaInfant formula - Extensively hydrolyzed Nutramigen Lipil

Eligibility Criteria

Age1 Day - 12 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Milk Hypersensitivity

Interventions

Infant Formula

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Milk SubstitutesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood, FormulatedFoods, SpecializedFoodInfant FoodFood and Beverages

Study Officials

  • Cynthia M Barber, PhD

    Perrigo Nutritionals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 7, 2009

First Posted

July 14, 2009

Study Start

August 1, 2007

Primary Completion

September 1, 2008

Study Completion

January 1, 2009

Last Updated

July 15, 2009

Record last verified: 2009-07