title: Use of OM-85 BV in children suffering from recurrent respiratory tract infections and subnormal IgG subclass levels.
abstract: BACKGROUND
  Recurrent acute respiratory tract infections (RARTIs) in children are related to IgG subclass deficiencies. The aim of the trial was to evaluate the effect of OM-85 BV in the number of RARTIs as well as in the IgG subclass levels.
  
  
  METHODS
  This was a randomized, double-blind, placebo-controlled clinical trial. Patients of ages three to six years, having three or more documented ARTIs during the last six months with subnormal IgG subclass levels were included. Patients took either one capsule of OM-85 BV (3.5 mg) or placebo orally every day for ten consecutive days per month during three consecutive months. Patients were followed three further months without drug intake. IgG subclass levels were determined before and after treatment.
  
  
  RESULTS
  IgG4 levels diminished after the OM-85 BV treatment (-3 [-8.0, -1.0] median difference [95 % CI] p < 0.05 by Wilcoxon test). No other significant changes in IgG subclasses were observed. After six months the patients in the OM-85 BV group (n = 20) experienced 2.8 1.4 (mean SD) ARTIs, while the patients in the placebo group (n = 20) suffered 5.2 1.5 ARTIs (-2.4 [3.3, -1.5] mean difference [95 % CI] p < 0.001 by Student's t test). Three patients with OM-85 BV had gastrointestinal events related to drug administration, as well as three placebo patients.
  
  
  CONCLUSIONS
  This study demonstrated the clinical benefit of OM-85 BV in patients suffering from RARTIs and subnormal levels of IgG subclasses. This trial opens new perspectives in the research of the mechanism of action of OM-85 BV.
authors.affiliation: Allergy Department, Hospital Infantil de México Federico Gómez, México City DF, México.
authors.forename: B E
authors.initials: BE
authors.lastname: Del-Río-Navarro
authors.forename: J J
authors.initials: JJ
authors.lastname: Luis Sienra-Monge
authors.forename: A
authors.initials: A
authors.lastname: Berber
authors.forename: S
authors.initials: S
authors.lastname: Torres-Alcántara
authors.forename: L
authors.initials: L
authors.lastname: Avila-Castañón
authors.forename: D
authors.initials: D
authors.lastname: Gómez-Barreto
mesh_terms: D000276:Adjuvants, Immunologic / Q000009:adverse effects / Q000627:therapeutic use*; D001419:Bacteria; D002457:Cell Extracts; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D017099:IgG Deficiency / Q000097:blood / Q000150:complications* / Q000628:therapy; D007074:Immunoglobulin G / Q000097:blood* / Q000145:classification; D007223:Infant; D008297:Male; D008800:Mexico; D011135:Polysaccharides, Bacterial / Q000276:immunology; D011446:Prospective Studies; D012008:Recurrence; D012141:Respiratory Tract Infections / Q000209:etiology / Q000276:immunology / Q000517:prevention & control*; D014505:Urban Population; D000095983:Bacterial Lysates
chemical_list: D000276:Adjuvants, Immunologic; D002457:Cell Extracts; D007074:Immunoglobulin G; D011135:Polysaccharides, Bacterial; C030259:Broncho-Vaxom; D000095983:Bacterial Lysates