NCT00732654

The Safety and Efficacy of Sublingual/Oral Immunotherapy for the Treatment of Milk Protein Allergy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 6 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if small oral and sublingual doses of milk protein are safe and effective in decreasing sensitivity to cow's milk in allergic children.

Conditions

• Milk Allergy

Interventions

Type	Name	Description
DRUG	Milk Protein Extract Immunotherapy goal of 4mg/day	Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.
DRUG	Milk Protein Extract Immunotherapy goal of 7mg/day	Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.
DRUG	Milk Powder Immunotherapy goal dose 2000 mg/day	Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.
DRUG	Milk Powder Immunotherapy goal dose 1000mg/day	Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-06-01
• Completion: 2012-06-01
• First posted: 2008-08-12
• Last updated: 2017-05-15
• Results posted: 2017-05-15

Locations

2 sites across 1 country: United States