|Abstract:||Background: Specific oral tolerance induction (SOTI) is a new therapeutic approach in the treatment of persistent food allergy. Objective: The purpose of this article is to systematically review the literature in order to identify, appraise, and synthesize the evidence about SOTI efficacy and safety. Methods: A comprehensive search for cita- tions was conducted on May 2, 2009 using MEDLINE via PubMed. Randomized controlled trials (RCT’s) including subjects of any age were considered. All these stu- dies were assessed, discussed in details and evaluated for quality by authors in a stan- dardized independent way. Results: 15 clinical trials were found. Of these, six trials met the inclusion criteria: three were open label RCT, three were double blind placebo controlled RCT. Two were conducted using sublingual immunotherapy, four using oral desensitization. Overall, the methodological quality of the studies was sufficient. The mean Jadad score of the studies was 3,33 (range = 2-5). Main characteristics and results of the studies were showed and discussed. Conclusions: SOTI seems to be a pos- sible approach to accelerate the development of tolerance in children affected by food al- lergy. However, other studies are needed to clarify which is the best treatment and protocol to follow in order to reduce the adverse events and to increase the percentage of success, before thinking that SOTI might be part of the clinical practice.