title: Bowman-Birk inhibitor concentrate: a novel therapeutic agent for patients with active ulcerative colitis.
abstract: Bowman-Birk inhibitor concentrate (BBIC), a soy extract with high protease inhibitor activity, is efficacious in the treatment of colitis in mice and has been used in numerous clinical trials. A randomized, double blind, placebo-controlled trial was performed to investigate the safety and possible benefits of BBIC in patients with active ulcerative colitis. The Sutherland Disease Activity Index (SDAI) was used to assess disease activity, response (Index decrease > or = 3), and remission (Index < or = 1 with no rectal bleeding) in patients receiving 12 weeks of therapy. The Index scores of patients receiving BBIC decreased more than those of the patients receiving placebo (P = 0.067). Beneficial trends were observed in the rates of remission (P = 0.082) and clinical response (P = 0.22). No severe adverse events were observed. This trial suggests a potential benefit over placebo for both achieving clinical response and induction of remission in patients with active ulcerative colitis without apparent toxicity.
authors.affiliation: Department of Medicine, Division of Gastroenterology, University of Pennsylvania School of Medicine, Philadelphia, PA 19104-4283, USA.
authors.forename: Gary R
authors.initials: GR
authors.lastname: Lichtenstein
authors.forename: Julius J
authors.initials: JJ
authors.lastname: Deren
authors.forename: Seymour
authors.initials: S
authors.lastname: Katz
authors.forename: James D
authors.initials: JD
authors.lastname: Lewis
authors.forename: Ann R
authors.initials: AR
authors.lastname: Kennedy
authors.forename: Jeffrey H
authors.initials: JH
authors.lastname: Ware
mesh_terms: D003093:Colitis, Ulcerative / Q000175:diagnosis / Q000188:drug therapy*; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D012074:Remission Induction; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014358:Trypsin Inhibitor, Bowman-Birk Soybean / Q000627:therapeutic use*; D014361:Trypsin Inhibitors / Q000627:therapeutic use*
chemical_list: D014358:Trypsin Inhibitor, Bowman-Birk Soybean; D014361:Trypsin Inhibitors