Milk oral immunotherapy is effective in school-aged children


  • Clinical trial registering: ClinicalTrials, Gov Id NCT01361347

Marita Paassilta, M.D., Ph.D., Allergy Centre, Tampere University Hospital, PB 2000, FIN-33521 Tampere, Finland.
Tel: +358 3 3116 7849 |
Fax: +358 3 311 64338 |


Aims:  To study the efficacy of oral immunotherapy (OIT) in schoolchildren with cow’s milk (CM) allergy (CMA).

Methods:  Twenty-eight children aged 6–14 years with CMA documented by oral challenge were enrolled into a randomized, double-blind, placebo-controlled OIT study. In the active treatment, CM protein amount was increased during 23 weeks from 0.06 mg to a maximum of 6400 mg (200 mL of milk).

Results:  Twenty-four (86%) patients completed the protocol: 16/18 in active and 8/10 in placebo groups. All children in the active and 2/3 in the placebo group suffered from symptoms considered by the parents as induced by milk. The children were contacted by phone 12 months later, and 13 (81%) used daily CM or milk products corresponding 6400 mg of CM protein. After double-blind OIT, all 10 children in the placebo group completed successfully an open-label OIT by an identical protocol, and all used daily CM or milk products 6 months later. Three to 3.5 years later, one child more had discontinued daily milk use. Thus, the long-term success rate was 22/28 (79%).

Conclusions:  This placebo-controlled, double-blind study confirmed that OIT was effective in desensitizing schoolchildren with CMA. With occasional exceptions, the reached desensitization sustained for more than 3 years.