title: The clearance effect of bovine anti-Helicobacter pylori antibody-containing milk in O blood group Helicobacter pylori-infected patients: a randomized double-blind clinical trial.
abstract: BACKGROUND
  The failure in standard triple therapy has recently increased to high levels in China, primarily because of insufficient patient compliance, antimicrobial resistance, and high costs. Effective prevention and eradication of Helicobacter pylori (H. pylori) by artificial passive immunization with orally administered bovine antibodies in the milk has been demonstrated in many animal studies, but the clinical studies that are available have shown no H. pylori eradication. This study was to evaluate the efficacy and safety of orally administered bovine anti-H. pylori antibodies for the clearance of H. pylori infecting O blood group subpopulations.
  
  
  METHODS
  Two local epidemic H. pylori strains that were prevalent locally were screened and then used to immunize dairy cows. After confirmation of the presence of anti-H. pylori polyclonal antibodies in the milk by enzyme-linked immunosorbent assay, the milk was subsequently defatted and processed into sterile milk by pasteurization. This study was designed as a double-blind placebo-controlled randomized clinical trial. Our 61 H. pylori-infected O blood group subjects were assigned to two groups; 31 subjects were treated with bovine milk containing antibodies and 30 subjects with the placebo. The medication-based study was continued for 28 days. Subjects were followed up for 56 days. The effect was assessed by the C-14 urea breath test (UBT). SPSS 17.0 software for Windows was used to analyze the data.
  
  
  RESULTS
  Of the 61 subjects enrolled, 58 completed the protocol. One volunteer in the antibodies group and two volunteers in the control group dropped out. Of the 30 antibody-treated subjects, 13 became UBT negative, whereas none of the 30 of the placebo-treated subjects became UBT negative after the medication. Of 13 UBT negative patients, 3 became positive again at the end of the follow-up. Both intention to treat and per-protocol analysis indicated a significant difference in the clearance rate of infected patients between the groups treated with bovine antibody-containing milk and the placebo (P = 0.001, P < 0.05) and no significant difference in adverse effects (P > 0.05 all).
  
  
  CONCLUSIONS
  Bovine antibody-based oral immunotherapy appears to be safe and has a significant clearance effect on intragastric H. pylori that infects O blood group adults.
  
  
  BACKGROUND
  ChiCTR-TRC-14005212.
authors.affiliation: Clinical Department, The Research Section of Experimentation Teaching Center, Hebei Medical University, Shijiazhuang, People's Republic of China. hebeimu2008@163.com.
authors.forename: Dailun
authors.initials: D
authors.lastname: Hu
authors.affiliation: The Institute of Cereal and Oil Crop, Hebei Academy of Agriculture and Forestry Sciences, Shijiazhuang, People's Republic of China. fengzhang76@163.com.
authors.forename: Feng
authors.initials: F
authors.lastname: Zhang
authors.affiliation: Shijiazhuang Center for Disease Control and Prevention, Shijiazhuang, People's Republic of China. zhoujikun1952@163.com.
authors.forename: Jikun
authors.initials: J
authors.lastname: Zhou
authors.affiliation: Shijiazhuang Center for Disease Control and Prevention, Shijiazhuang, People's Republic of China. baohongxu1965@163.com.
authors.forename: Baohong
authors.initials: B
authors.lastname: Xu
authors.affiliation: Shijiazhuang Center for Disease Control and Prevention, Shijiazhuang, People's Republic of China. hongyingzhang1969@163.com.
authors.forename: Hongying
authors.initials: H
authors.lastname: Zhang
authors.affiliation: Shijiazhuang Center for Prevention and Control of Animal Diseases, Shijiazhuang, People's Republic of China. huiqinqiang@163.com.
authors.forename: Huiqin
authors.initials: H
authors.lastname: Qiang
authors.affiliation: The Fourth Hospital of Hebei Medical University, Shijiazhuang, People's Republic of China. shuguangren1976@163.com.
authors.forename: Shuguang
authors.initials: S
authors.lastname: Ren
authors.affiliation: The Fourth Hospital of Hebei Medical University, Shijiazhuang, People's Republic of China. baoenshan62@163.com.
authors.forename: Baoen
authors.initials: B
authors.lastname: Shan
authors.affiliation: Clinical Department, The Research Section of Experimentation Teaching Center, Hebei Medical University, Shijiazhuang, People's Republic of China. yinchangfu1962@163.com.
authors.forename: Changfu
authors.initials: C
authors.lastname: Yin
authors.affiliation: Clinical Department, The Research Section of Experimentation Teaching Center, Hebei Medical University, Shijiazhuang, People's Republic of China. zhitaozhang1982@163.com.
authors.forename: Zhitao
authors.initials: Z
authors.lastname: Zhang
authors.affiliation: Shijiazhuang Center for Disease Control and Prevention, Shijiazhuang, People's Republic of China. xianwang1963@163.com.
authors.forename: Xian
authors.initials: X
authors.lastname: Wang
authors.affiliation: Shijiazhuang Center for Disease Control and Prevention, Shijiazhuang, People's Republic of China. chuanzhao1962@163.com.
authors.forename: Chuan
authors.initials: C
authors.lastname: Zhao
authors.affiliation: Clinical Department, The Research Section of Experimentation Teaching Center, Hebei Medical University, Shijiazhuang, People's Republic of China. shizhongli1963@163.com.
authors.forename: Zhongli
authors.initials: Z
authors.lastname: Shi
mesh_terms: D000017:ABO Blood-Group System / Q000276:immunology*; D000328:Adult; D000368:Aged; D000818:Animals; D000907:Antibodies, Bacterial / Q000009:adverse effects / Q000276:immunology*; D002417:Cattle; D004311:Double-Blind Method; D016481:Helicobacter Infections / Q000276:immunology* / Q000382:microbiology*; D016480:Helicobacter pylori / Q000276:immunology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008892:Milk / Q000009:adverse effects / Q000276:immunology*; D010865:Pilot Projects; D011795:Surveys and Questionnaires; D055815:Young Adult
chemical_list: D000017:ABO Blood-Group System; D000907:Antibodies, Bacterial