Abstract
BackgroundThe 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.MethodsTwo 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.ResultsOf 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).ConclusionsBovine antibody-based oral immunotherapy appears to be safe and has a significant clearance effect on intragastric H. pylori that infects O blood group adults.Trial registration: ChiCTR-TRC-14005212.
Highlights
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
The phenotype of the Lewis blood-group antigens in the LPS of two H. pylori strains was analyzed by serological studies, by using Lewis blood-group-specific Lea, Leb, Lex, Ley monoclonal antibodies (Santa Cruz Biotechnology Inc, Dallas, TX, USA) on whole cells by enzyme-linked immunosorbent assay (ELISA), respectively, with both indicating the presence of the type-1 Leb epitope on the cell surface [32, 33]
Two H. pylori strains, which were preserved as frozen stocks at −80°C in brain heart infusion media supplemented with 20% glycerol and 10% fetal bovine serum (FBS), were revived and cultured on Columbia Agar medium plates (Oxoid Ltd., Basingstoke, Hampshire, England) supplemented with 10% defibrinated sheep blood, 5 mg/L trimethoprim, 5 mg/L polymixin-B, 5 mg/L amphoteracin-B, and 10 mg/L vancomucin, under microaerobic conditions (10% CO2, 85% N2, 5% O2) at 37°C for Product size
Summary
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. 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. Different geographic regions have different combination of vacA allele and cagA. These variations in the global distribution of the cagA and vacA genotypes might account for the diversity of reports associating the cagA and vacA genotypes with the clinical outcome from these different regions. Detailed structural studies have shown that the LPSs of H. pylori are unique in that their O-chain region is homologous to mammalian histo-blood group antigens. Individuals of the O blood group are prone to H. pylori infection because their gastric epithelium highly expresses the Leb antigen, which is the BabA of H. pylori binding sites [10, 11]
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