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

Director of Research Division

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01863823
Enrollment
350
Registered
2013-05-29
Start date
2011-08-31
Completion date
2012-09-30
Last updated
2013-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Helicobacter Pylori

Keywords

Symptomatic patients, asymptomatic individuals, clinical trial

Brief 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.

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.

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.

DRUGMouth washing

Two time washing mouth per day

Sponsors

Ameritek USA
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* patients with gastrointestinal complaints

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Success Rate12 months

Secondary

MeasureTime frame
Diagnostic6 months

Other

MeasureTime frame
Agreement of diagnostic and success rate of gastric eradication12 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026