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An Interventional Study of Milk Allergy

NCT00578656 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2012-08-01

No results posted yet for this study

Summary

Milk is the among the most common food allergens in infants and children. The majority of children outgrow their allergies; however, the exact mechanisms by which food tolerance is achieved are unknown. Strict avoidance of the offending food is currently the only known therapy. However, subjects have been known to lose food hypersensitivity while frequently ingesting small amounts of processed forms of the offending product. The purpose of this study is to investigate whether ingestion of small amounts of processed milk protein will be permitted without compromising the chances of either outgrowing milk hypersensitivity or prolonging the time needed to achieve clinical tolerance.

Conditions

  • Food Hypersensitivity
  • Milk Hypersensitivity

Interventions

DIETARY_SUPPLEMENT

Baked Milk

Extensively heated milk

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Hugh A. Sampson, MD

  • Scott H. Sicherer, MD

  • Anna Nowak-Wegrzyn, MD

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Min Age
4 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2011-02-28
Completion
2011-02-28

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 NCT00578656 on ClinicalTrials.gov