BACKGROUND: Antibiotic-based regimens are frequently used for the treatment of Helicobacter pylori infection. These regimens fail to eradicate H pylori in 15% to 40% of patients, primarily due to antimicrobial resistance and insufficient patient compliance. Effective prevention and eradication of H pylori by passive immunization with orally administered bovine antibodies has been demonstrated in animal studies, and may serve as an alternative therapy in humans. OBJECTIVE: To study the efficacy and safety of orally administered bovine anti-H pylori antibodies for the reduction of intragastric bacterial load and eradication of H pylori in humans. METHODS:Dairy cows were immunized against H pylori. After confirmation of the presence of anti-H pylori antibodies in the milk, the milk was subsequently processed into a whey protein concentrate (WPC). In a prospective, double-blind, placebo-controlled randomized clinical trial, H pylori-infected subjects were randomly assigned to treatment with the WPC preparation or placebo. Study medication was continued for 28 days; subjects were followed-up for 56 days. RESULTS: Of the 30 subjects included, 27 completed the protocol. Of these 27 evaluable subjects, 14 were treated with WPC and 13 withplacebo. There was no significant difference in urea breath test decrease between the WPC- and placebo-treated group (P=0.75). H pylori-associated gastritis and density were not significantly reduced in either group after treatment (P>0.05 for all). CONCLUSION:Bovine antibody-based oral immunotherapy appears to be safe, but does not significantly reduce intragastric density in humans. Further studies are needed to determine whether WPC treatment has additional value to conventional antibiotic treatment for H pylori.
RCT Entities:
BACKGROUND: Antibiotic-based regimens are frequently used for the treatment of Helicobacter pylori infection. These regimens fail to eradicate H pylori in 15% to 40% of patients, primarily due to antimicrobial resistance and insufficientpatient compliance. Effective prevention and eradication of H pylori by passive immunization with orally administered bovine antibodies has been demonstrated in animal studies, and may serve as an alternative therapy in humans. OBJECTIVE: To study the efficacy and safety of orally administered bovine anti-H pylori antibodies for the reduction of intragastric bacterial load and eradication of H pylori in humans. METHODS: Dairy cows were immunized against H pylori. After confirmation of the presence of anti-H pylori antibodies in the milk, the milk was subsequently processed into a whey protein concentrate (WPC). In a prospective, double-blind, placebo-controlled randomized clinical trial, H pylori-infected subjects were randomly assigned to treatment with the WPC preparation or placebo. Study medication was continued for 28 days; subjects were followed-up for 56 days. RESULTS: Of the 30 subjects included, 27 completed the protocol. Of these 27 evaluable subjects, 14 were treated with WPC and 13 with placebo. There was no significant difference in urea breath test decrease between the WPC- and placebo-treated group (P=0.75). H pylori-associated gastritis and density were not significantly reduced in either group after treatment (P>0.05 for all). CONCLUSION:Bovine antibody-based oral immunotherapy appears to be safe, but does not significantly reduce intragastric density in humans. Further studies are needed to determine whether WPC treatment has additional value to conventional antibiotic treatment for H pylori.
Authors: G P Davidson; P B Whyte; E Daniels; K Franklin; H Nunan; P I McCloud; A G Moore; D J Moore Journal: Lancet Date: 1989-09-23 Impact factor: 79.321
Authors: K Seppälä; T U Kosunen; H Nuutinen; P Sipponen; H Rautelin; S Sarna; H Hyvärinen; M Färkkilä; T A Miettinen Journal: Scand J Gastroenterol Date: 2000-09 Impact factor: 2.423
Authors: F Canducci; A Armuzzi; F Cremonini; G Cammarota; F Bartolozzi; P Pola; G Gasbarrini; A Gasbarrini Journal: Aliment Pharmacol Ther Date: 2000-12 Impact factor: 8.171
Authors: Pertti Marnila; Susanna Rokka; Leena Rehnberg-Laiho; Päivi Kärkkäinen; Timo U Kosunen; Hilpi Rautelin; Marja-Liisa Hänninen; Eeva-Liisa Syväoja; Hannu Korhonen Journal: Helicobacter Date: 2003-06 Impact factor: 5.753
Authors: A Cats; E J Kuipers; M A R Bosschaert; R G J Pot; C M J E Vandenbroucke-Grauls; J G Kusters Journal: Aliment Pharmacol Ther Date: 2003-02 Impact factor: 8.171
Authors: T H Casswall; H O Nilsson; L Björck; S Sjöstedt; Li Xu; C K Nord; T Borén; T Wadström; L Hammarström Journal: Scand J Gastroenterol Date: 2002-12 Impact factor: 2.423
Authors: H Suzuki; S Nomura; T Masaoka; H Goshima; N Kamata; Y Kodama; H Ishii; M Kitajima; K Nomoto; T Hibi Journal: Aliment Pharmacol Ther Date: 2004-07 Impact factor: 8.171