Evidence map›Paper›PMID 26123101›Full record

Trial reportJournal of translational medicine2015

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.

Dailun Hu, Feng Zhang, Jikun Zhou, Baohong Xu, Hongying Zhang, Huiqin Qiang, Shuguang Ren, Baoen Shan, Changfu Yin, Zhitao Zhang and 3 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of translational medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.9field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 17 citations in OpenAlex.

  1. Review
  2. Article
  3. Therapeutic suppression ofFrontiers in microbiology · 2026
    Article
  4. Review
  5. Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 4 institutions in 1 country.

Dailun HuClinical Department, The Research Section of Experimentation Teaching Center, Hebei Medical University, Shijiazhuang, People's Republic of China. hebeimu2008@163.com.
Feng ZhangThe Institute of Cereal and Oil Crop, Hebei Academy of Agriculture and Forestry Sciences, Shijiazhuang, People's Republic of China. fengzhang76@163.com.
Jikun ZhouShijiazhuang Center for Disease Control and Prevention, Shijiazhuang, People's Republic of China. zhoujikun1952@163.com.
Baohong XuShijiazhuang Center for Disease Control and Prevention, Shijiazhuang, People's Republic of China. baohongxu1965@163.com.
Hongying ZhangShijiazhuang Center for Disease Control and Prevention, Shijiazhuang, People's Republic of China. hongyingzhang1969@163.com.
Huiqin QiangShijiazhuang Center for Prevention and Control of Animal Diseases, Shijiazhuang, People's Republic of China. huiqinqiang@163.com.
Shuguang RenThe Fourth Hospital of Hebei Medical University, Shijiazhuang, People's Republic of China. shuguangren1976@163.com.
Baoen ShanThe Fourth Hospital of Hebei Medical University, Shijiazhuang, People's Republic of China. baoenshan62@163.com.
Changfu YinClinical Department, The Research Section of Experimentation Teaching Center, Hebei Medical University, Shijiazhuang, People's Republic of China. yinchangfu1962@163.com.
Zhitao ZhangClinical Department, The Research Section of Experimentation Teaching Center, Hebei Medical University, Shijiazhuang, People's Republic of China. zhitaozhang1982@163.com.
Xian WangShijiazhuang Center for Disease Control and Prevention, Shijiazhuang, People's Republic of China. xianwang1963@163.com.
Chuan ZhaoShijiazhuang Center for Disease Control and Prevention, Shijiazhuang, People's Republic of China. chuanzhao1962@163.com.
Zhongli ShiClinical Department, The Research Section of Experimentation Teaching Center, Hebei Medical University, Shijiazhuang, People's Republic of China. shizhongli1963@163.com.
Hebei Provincial Center for Disease Control and Prevention · CNHebei Medical University · CNFourth Hospital of Hebei Medical University · CNHebei Academy of Agriculture and Forestry Sciences · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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 registrationChiCTR-TRC-14005212.

Indexed as

ABO Blood-Group SystemAdultAgedAnimalsAntibodies, BacterialCattleDouble-Blind MethodHelicobacter InfectionsHelicobacter pyloriHumansMaleMiddle AgedMilkPilot ProjectsSurveys and QuestionnairesYoung AdultABO Blood-Group SystemAntibodies, Bacterial

Identifiers

PMID26123101
PMCPMC4484630
OpenAlexW1500236483

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.