title: [Double-blind study of an immunomodulator of bacterial origin (Biostim) in the prevention of infectious episodes in chronic bronchitis].
abstract: A double-blind trial was conducted to evaluate the capacity of an immunomodulator of bacterial origin (Biostim) to diminish the frequency of infectious episodes in chronic bronchitis. The study duration was 9 months, Biostim being administered orally initially, with follow-up examinations after 2 and 4 months. Of the 73 subjects selected, 38 received Biostim and 35 a placebo (no significant differences between the two groups). By the 9th month, the duration in days of infectious episodes and of antibiotic therapy was 13 +/- 1.3 and 11.5 +/- 1.4 days respectively for the group receiving Biostim, and 33 +/- 5.8 and 41 +/- 9.5 respectively for the placebo group (p less than 0.05). No signs of intolerance and particularly no immunotoxicity were observed: absence of elevation of IgE or anti-Biostim antibody titres. Pre-winter administration of Biostim to subjects at high risk would appear to significantly diminish the frequency of infectious episodes and thus the consumption of antibiotics.
mesh_terms: D000276:Adjuvants, Immunologic / Q000494:pharmacology / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000517:prevention & control*; D001426:Bacterial Proteins; D001991:Bronchitis / Q000628:therapy*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D006023:Glycoproteins / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D007111:Immunity, Cellular / Q000187:drug effects; D009504:Neutrophils / Q000187:drug effects; D014777:Virus Diseases / Q000517:prevention & control*
chemical_list: D000276:Adjuvants, Immunologic; D001426:Bacterial Proteins; D006023:Glycoproteins; C037567:glycoprotein, Klebsiella pneumoniae
vernacular_title: Etude en double aveugle d'un immunomodulateur d'origine bactérienne (Biostim) dans la prévention des épisodes infectieux chez le bronchitique chronique.