E Barbi

Dr E Barbi, University of Trieste, Trieste, Italy; ebarbi@libero.it

STUDY DESIGN

Design:

randomised controlled trial.

Allocation:

concealed.*

Blinding:

unblinded.*

STUDY QUESTION

Setting:

children’s hospital in Trieste, Italy.

Patients:

60 children 5–17 years of age (mean age 8 y, 65% boys) who had a history of severe allergic reaction after exposure to milk or dairy products, milk-specific serum IgE concentrations >85 kUA/l, and a positive reaction to a double-blind, placebo-controlled food challenge of ⩽0.8 ml of whole milk. Exclusion criteria were unreliable management of complications by parents, limited access to emergency care, and poorly controlled asthma.

Intervention:

specific oral tolerance induction (SOTI) (n = 30) or maintenance of a milk-free diet (n = 30). The SOTI protocol consisted of 10 days in hospital during which children were given rapidly increasing doses of milk, up to 20 ml whole milk/dose. At home, children continued with …