title: A double blind, randomized, placebo controlled trial of the efficacy, quality of life and safety of food allergen-specific sublingual immunotherapy in client owned dogs with adverse food reactions: a small pilot study.
abstract: BACKGROUND
  Food allergen-specific sublingual immunotherapy (FA-SLIT) has emerged as a novel and successful approach for desensitizing human patients to specific food allergens. It has not been tested in dogs.
  
  
  OBJECTIVE
  To investigate the efficacy, quality of life (QoL), tolerability and safety of FA-SLIT in dogs with adverse food reactions (AFR).
  
  
  METHODS
  Dogs with proven AFR were randomized to treatment (T group; n = 7) or placebo (P group; n = 6) to receive either FA-SLIT (based on the results of a food elimination trial) or glycerinated saline, respectively. The treatment was continued daily for 6 months with fortnightly dosage escalations. To evaluate the treatment, pruritus Visual Analog Scale (pVAS), Canine Atopic Dermatitis Extent and Severity Index (CADESI-04), QoL, faecal consistency scores, owner assessment, overall tolerability scores and blood analyses were assessed.
  
  
  RESULTS
  Eleven dogs completed the study, two dogs in the T group were withdrawn by the owner after FA-SLIT exacerbated clinical signs of AFR. Statistical tests showed significant protection against food challenge induced clinical signs following FA-SLIT therapy, as indicated by reduced pVAS and CADESI scores (P < 0.05). The QoL did not differ between groups. The treatment was rated as effective or quite effective by 80% of the owners, whereas placebo was rated as ineffective by all owners.
  
  
  CONCLUSIONS
  FA-SLIT was effective, well tolerated and safe. No severe adverse events were recorded; erythema and pruritus were reported in association with only 0.7% of the dispensed doses. Larger clinical trials with more extended maintenance immunotherapy periods will be needed to provide more precise estimates of efficacy and frequency of adverse events.
authors.affiliation: Laboratory of Immunology, Ghent University of Veterinary Medicine, Salisburylaan 133, Merelbeke, 9820, Belgium. elisa.maina@ugent.be.
authors.forename: Elisa
authors.initials: E
authors.lastname: Maina
authors.affiliation: Laboratory of Immunology, Ghent University of Veterinary Medicine, Salisburylaan 133, Merelbeke, 9820, Belgium.
authors.forename: Eric
authors.initials: E
authors.lastname: Cox
mesh_terms: D000485:Allergens / Q000008:administration & dosage*; D000818:Animals; D003888:Desensitization, Immunologic / Q000379:methods / Q000662:veterinary*; D004283:Dog Diseases / Q000628:therapy*; D004285:Dogs; D004311:Double-Blind Method; D005512:Food Hypersensitivity / Q000276:immunology / Q000662:veterinary*; D007167:Immunotherapy / Q000662:veterinary*; D010865:Pilot Projects; D011537:Pruritus / Q000662:veterinary; D063729:Sublingual Immunotherapy
chemical_list: D000485:Allergens