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A Growth and Hypoallergenicity Study of a New Formula for Infants With Cow Milk Allergy

NCT00664768 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2020-12-09

No results posted yet for this study

Summary

This study involves the use of 2 different Neocate formulas: a control formula called Neocate Infant and a test Neocate formula. These kinds of formulas are for use in children from birth to 8 months of age with Cow Milk Allergy (CMA), other food allergies, and other gastrointestinal disorders. The purpose of this study is to compare the control and test Neocate formulas for safety, tolerability, and effectiveness (in promoting growth) when used in subjects with CMA.

This study will also look at the test Neocate formula to see if it is hypoallergenic when used in subjects with CMA.

Conditions

  • Cow Milk Allergy

Interventions

DIETARY_SUPPLEMENT

Neocate Infant

minimum of 8 fl. oz daily

DIETARY_SUPPLEMENT

new Neocate

minimum of 8 fl oz daily

Sponsors & Collaborators

  • Nutricia Liverpool

    collaborator INDUSTRY

  • Danone Institute International

    collaborator OTHER

  • Nutricia North America

    lead INDUSTRY

Principal Investigators

  • Barbara Mourmans · Study Mgr Nutricia Research - Centre for Specialised Nutrition

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
8 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00664768 on ClinicalTrials.gov