Conditions: Milk Allergy
Keywords: Food Allergy Oral Immunotherapy Immunoglobulin E
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 30
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.

Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years. arm 2: These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.

Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years. arm 3: These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.

Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.

Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.

Interventions: intervention 1: Milk Protein Extract Immunotherapy goal of 4mg/day intervention 2: Milk Protein Extract Immunotherapy goal of 7mg/day intervention 3: Milk Powder Immunotherapy goal dose 2000 mg/day intervention 4: Milk Powder Immunotherapy goal dose 1000mg/day
Intervention descriptions: intervention 1: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks. intervention 2: Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years. intervention 3: Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years. intervention 4: Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.

Protocol document: