CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 170 enrolled
Drug / intervention
Baked Milk +1 morebiological
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/NCT00778258
NCT00778258Phase 2Completed
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Dietary Intervention in Milk Allergy and Tolerance Development

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Oct 23, 2008·Updated Mar 30, 2016

In Brief

A Phase 2 clinical trial evaluating Baked Milk and Non-baked Milk for Food Hypersensitivity and Milk Hypersensitivity. Completed, enrolled 170 participants across 1 site.

Detailed Summary

The purpose of this study is to determine if children who are allergic to milk can increase tolerance through frequent dose-escalation every 6 months versus 12 months leading to eventual tolerance of less heated milk and ultimately unheated milk.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFood Hypersensitivity, Milk Hypersensitivity
CountriesUnited States
CollaboratorsAsthma and Allergic Diseases Cooperative Research Centers

Timeline

Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 23, 2008
Enrollment StartAug 1, 2008
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 17.7 years ago

Interventions

Baked Milkbiological

At baseline, each subject will undergo sequential oral food challenges with the products that contain increasing amounts of milk protein that are baked: Stage 1 (muffin), Stage 2 (pizza), and Stage 3 (rice pudding) doses of baked milk to determine the extent to which they tolerate various baked milk proteins. Based on the outcomes of the baseline oral food challenges, subjects will be assigned to one of the 5 study arms.

Non-baked Milkbiological

Those subjects tolerant to rice pudding will undergo oral food challenge with non-baked milk.