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An Elimination Diet Using a New Amino Acid Based Formula: Immunological and Clinical Effects in Cow's Milk Allergy

NCT01109966 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2017-05-08

No results posted yet for this study

Summary

The purpose of this study is to evaluate whether a new version of an amino acid based formula improves tolerance to milk in cow's milk allergic infants/young children.

Conditions

Interventions

OTHER

Special Medical Food

Comparison between a standard amino acid based formula and a new amino acid based formula. Subjects with CMA will take their randomised formula for 12 months. Following completion of the intervention (12 months), subjects will transfer to an age appropriate formula and be followed-up at 24 and 36 months. Infants should typically consume the following amounts of formula during the study \> 500mls/day up to 12 months of age \> 400mls/day between 12 and 18 months of age \> 300mls/day over 18 months of age.

OTHER

Special Medical Food

Comparison between a standard amino acid based formula and a new amino acid based formula. Subjects with CMA will take their randomised formula for 12 months. Following completion of the intervention (12 months), subjects will transfer to an age appropriate formula and be followed-up at 24 and 36 months. Infants should typically consume the following amounts of formula during the study \> 500mls/day up to 12 months of age \> 400mls/day between 12 and 18 months of age \> 300mls/day over 18 months of age.

Sponsors & Collaborators

  • Nutricia Research

    lead INDUSTRY

Principal Investigators

  • Kirsten Beyer, MD · Hospital Charité

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
8 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • France
  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT01109966 on ClinicalTrials.gov