NCT00778258

Study of Milk Allergy and Tolerance in Children

Dietary Intervention in Milk Allergy and Tolerance Development

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 4 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Milk is among the most common food allergens in infants and children. The majority of children outgrow their milk 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, some have been known to tolerate milk products cooked at high heat such as when baked in foods. This clinical trial involves a diet containing extensively baked milk protein to investigate the effects of ingestion of heat-denatured milk on development of oral tolerance to non-baked milk.

Conditions

• Food Hypersensitivity
• Milk Hypersensitivity

Interventions

Type	Name	Description
BIOLOGICAL	Baked Milk	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.
BIOLOGICAL	Non-baked Milk	Those subjects tolerant to rice pudding will undergo oral food challenge with non-baked milk.

Timeline

• Start date: 2008-08-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2008-10-23
• Last updated: 2016-03-30
• Results posted: 2016-03-30

Locations

1 site across 1 country: United States