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CompletedNCT01863823Updated May 29, 2013

The Effective Treatment of Oral Helicobacter Pylori With the Success Rate of Gastric Eradication

A Phase 1/2 interventional study of Amoxicillin and Tetracyclines and Mouth washing in Oral Helicobacter Pylori, sponsored by Ameritek USA. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2013-05-29.

Sponsored by Ameritek USA · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
350
Allocation
Randomized
Sex
All
01

Study summary

  1. Gastric eradication has no effective on oral H. pylori infection.
  2. Treatment of oral infection increase success rate of eradication on stomach infection.
Read the detailed description

Objective: The present study was aimed to explore the relationship of Helicobacter pylori(H. pylori) of the oral cavity with the success rate eradication of gastric H. pylori infection.

Study Design and Setting: 202 symptomatic and 148 asymptomatic individuals were recruited and tested using Saliva H. pylori antigen tests (HPS), H. pylori flagellin (HPF), the urea breathe test (UBT) and the polymerase chain reaction (PCR) test. Test subjects also received various treatments.

We collected data of HPS, HPF , PCR and UBT before treatment on 202 symptomatic patients and 148 asymptomatic individual groups. After drug treatment, we run HPS, HPF, PCR and UBT tests. If the tests of HPS, HPF and PCR show negative that indicate success of oral H.pylori eradication. If the test of UBT show negative that indicate success of stomach H.pyloi eradication. We also compare the suceess rate of eradication on stomach infection with and without oral H. pylori infection.

02

Conditions studied

  • Oral Helicobacter Pylori

Keywords

  • Symptomatic patients
  • asymptomatic individuals
  • clinical trial
03

In context

Lead sponsor

This is the only study on the registry with Ameritek USA as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • patients with gastrointestinal complaints

Exclusion criteria

Exclusion Criteria:

  • patients who had taken any antibiotics and/or proton pump inhibitors within four weeks prior to sample collection
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
350 participants (actual)

Study arms

  • Other
    Amoxicillin and Tetracyclines

    drug treatment

    Drug: Amoxicillin and Tetracyclines

  • Other
    Mouth washing

    Mouth washing

    Drug: Mouth washing

Interventions

  • DrugAmoxicillin and Tetracyclines

    202 symptomatic and 148 asymptomatic individuals were recruited and tested using Saliva H. pylori antigen tests (HPS), H. pylori flagellin (HPF), the urea breathe test (UBT) and the polymerase chain reaction (PCR) test. Test subjects also received various treatments.

    Also known as: dBest

  • DrugMouth washing

    Two time washing mouth per day

    Also known as: dBest

06

What researchers measure

Primary outcomes

  1. Success Rate

    Time frame: 12 months

Secondary outcomes

  1. Diagnostic

    Time frame: 6 months

Other outcomes

  1. Agreement of diagnostic and success rate of gastric eradication

    Time frame: 12 months

07

Study locations

1 site
  • Beijing University First Hospital
    Beijiang, 1001, China
08

References and documents

Publications

  • Wang XM, Yee KC, Hazeki-Taylor N, Li J, Fu HY, Huang ML, Zhang GY. Oral Helicobacter pylori, its relationship to successful eradication of gastric H. pylori and saliva culture confirmation. J Physiol Pharmacol. 2014 Aug;65(4):559-66. PubMed 25179088 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01863823
Lead sponsor
Ameritek USA
Responsible party
K C Yee (Director of Research Division, Ameritek USA) — Principal investigator
First posted
May 29, 2013
Start date
Aug 2011
Primary completion
Sep 2012
Completion
Sep 2012
Last update
May 29, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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