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.
Author(s): Hu D(1), Zhang F(2), Zhou J(3), Xu B(4), Zhang H(5), Qiang H(6), Ren S(7), Shan
B(8), Yin C(9), Zhang Z(10), Wang X(11), Zhao C(12), Shi Z(13).
Affiliation(s): Author information:
(1)Clinical Department, The Research Section of Experimentation Teaching Center,
Hebei Medical University, Shijiazhuang, People's Republic of China.
hebeimu2008@163.com. (2)The Institute of Cereal and Oil Crop, Hebei Academy of
Agriculture and Forestry Sciences, Shijiazhuang, People's Republic of China.
fengzhang76@163.com. (3)Shijiazhuang Center for Disease Control and Prevention,
Shijiazhuang, People's Republic of China. zhoujikun1952@163.com. (4)Shijiazhuang
Center for Disease Control and Prevention, Shijiazhuang, People's Republic of
China. baohongxu1965@163.com. (5)Shijiazhuang Center for Disease Control and
Prevention, Shijiazhuang, People's Republic of China. hongyingzhang1969@163.com.
(6)Shijiazhuang Center for Prevention and Control of Animal Diseases,
Shijiazhuang, People's Republic of China. huiqinqiang@163.com. (7)The Fourth
Hospital of Hebei Medical University, Shijiazhuang, People's Republic of China.
shuguangren1976@163.com. (8)The Fourth Hospital of Hebei Medical University,
Shijiazhuang, People's Republic of China. baoenshan62@163.com. (9)Clinical
Department, The Research Section of Experimentation Teaching Center, Hebei
Medical University, Shijiazhuang, People's Republic of China.
yinchangfu1962@163.com. (10)Clinical Department, The Research Section of
Experimentation Teaching Center, Hebei Medical University, Shijiazhuang, People's
Republic of China. zhitaozhang1982@163.com. (11)Shijiazhuang Center for Disease
Control and Prevention, Shijiazhuang, People's Republic of China.
xianwang1963@163.com. (12)Shijiazhuang Center for Disease Control and Prevention,
Shijiazhuang, People's Republic of China. chuanzhao1962@163.com. (13)Clinical
Department, The Research Section of Experimentation Teaching Center, Hebei
Medical University, Shijiazhuang, People's Republic of China.
shizhongli1963@163.com.
Publication date & source: 2015, J Transl Med. , 13:205
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.
TRIAL REGISTRATION: ChiCTR-TRC-14005212.
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