NCT03462030

Baked Milk Oral Immunotherapy for Cow's Milk Allergy

Phase II Study of Baked Milk Oral Immunotherapy for the Treatment of Cow's Milk Allergy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether baked milk oral immunotherapy is safe in the treatment of cow's milk allergy.

Detailed description

This study is designed to assess the safety of baked milk oral immunotherapy among patients who are milk allergic and who do not pass a baked milk challenge.

Conditions

• Cow's Milk Allergy

Interventions

Type	Name	Description
DRUG	Baked non-fat cow's milk powder	Oral immunotherapy with increasing quantities of baked milk.
DRUG	Placebo: Tapioca Powder	Placebo control.

Timeline

• Start date: 2018-03-15
• Primary completion: 2021-01-25
• Completion: 2024-02-19
• First posted: 2018-03-12
• Last updated: 2025-02-04
• Results posted: 2021-12-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study