CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 220 enrolled
Drug / intervention
Baked Milkdietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00578656
NCT00578656Early Ph 1Completed

The Impact of the Diet Containing Limited Amounts of Processed Milk Protein on the Natural History of IgE-Mediated Milk Hypersensitivity

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Dec 21, 2007·Updated Aug 1, 2012

In Brief

A Early Phase 1 clinical trial evaluating Baked Milk for Food Hypersensitivity and Milk Hypersensitivity. Completed, enrolled 220 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 21, 2007
Enrollment StartJun 1, 2004
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 18.5 years ago

Interventions

Baked Milkdietary

Extensively heated milk