title: Effects of oral bacterial immunotherapy in children with atopic eczema/dermatitis syndrome : a pilot study.
abstract: BACKGROUND
  Atopic eczema/dermatitis syndrome (AEDS) is a chronic inflammatory skin disease, affecting 10-20% of children and 1-3% of adults. The purpose of this pilot study was to assess the clinical and anti-inflammatory effect of bacterial and ribosomal immunotherapy with Immucytal (Pierre Fabre Médicament, France) in children with AEDS.
  
  
  METHODS
  Seventeen children with allergic and non-allergic forms of AEDS (AAEDS and NAAEDS, respectively), graded moderate to severe (Severity Scoring of Atopic Dermatitis [SCORAD] index of >25), received ribosomal immunotherapy (Immucytal) once daily according to the standard treatment regimen (4 consecutive days a week for 3 weeks, and then 4 consecutive days a month for 4 months). We assessed the clinical status of AEDS using the SCORAD index at baseline, and after 8 and 20 weeks of treatment. Furthermore, peripheral blood from patients was examined for the frequencies of CD4+ cells expressing interferon (IFN)-gamma and interleukin (IL)-4 using flow cytometry.
  
  
  RESULTS
  There was a progressive and significant clinical improvement of AEDS, confirmed by a reduction of the SCORAD index over time in both AEDS forms (p < 0.01). Pooled data from the two groups showed that the mean baseline index of 43 was reduced to 17 after treatment. Overall, these data indicate a marked improvement in total clinical severity of AEDS (-62%). Flow cytometry analysis showed that frequencies of the two CD4+ T cell subsets did not differ significantly from the beginning to the end of the study in both forms of AEDS. However, the percentage of CD4+ cells expressing IL-4 in children with AAEDS tended to decrease by the end of treatment with ribosomal immunotherapy. Clinical and laboratory data confirmed that immunotherapy was well tolerated.
  
  
  CONCLUSIONS
  The results of this pilot investigation suggest that ribosomal immunotherapy may be beneficial in the management of AEDS in children, and that this could be at least partially explained by a role in restoring the type 2 helper-T cell imbalance seen in allergic patients. Placebo-controlled, randomized clinical trials are recommended in order to confirm these findings.
authors.affiliation: Department of Pediatrics, Division S. Maggiore, University of Bari, Italy. l.brunetti@pediatria3.uniba.it
authors.forename: Luigia
authors.initials: L
authors.lastname: Brunetti
authors.forename: Ruggiero
authors.initials: R
authors.lastname: Francavilla
authors.forename: Riccardina
authors.initials: R
authors.lastname: Tesse
authors.forename: Patrizia
authors.initials: P
authors.lastname: Fiermonte
authors.forename: Porzia
authors.initials: P
authors.lastname: Dambra
authors.forename: Mariacristina
authors.initials: M
authors.lastname: Massagli
authors.forename: Maria P
authors.initials: MP
authors.lastname: Loria
authors.forename: Lucio
authors.initials: L
authors.lastname: Armenio
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000627:therapeutic use*; D000284:Administration, Oral; D000293:Adolescent; D000942:Antigens, Bacterial / Q000008:administration & dosage / Q000627:therapeutic use*; D015496:CD4-Positive T-Lymphocytes / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000276:immunology / Q000628:therapy*; D005260:Female; D005434:Flow Cytometry; D006801:Humans; D007167:Immunotherapy / Q000379:methods*; D007371:Interferon-gamma / Q000276:immunology; D015847:Interleukin-4 / Q000276:immunology; D008297:Male; D010865:Pilot Projects
chemical_list: D000276:Adjuvants, Immunologic; D000942:Antigens, Bacterial; C034206:Ribomunyl; D015847:Interleukin-4; D007371:Interferon-gamma