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

Phase 1

Completed

• Conditions: Oral Helicobacter Pylori
• Interventions: Drug: Amoxicillin and Tetracyclines; Drug: Mouth washing

• Registration Number: NCT01863823
• Lead Sponsor: Ameritek USA

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.

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-05
• Study First Submitted: 2013-05-10
• Study First Submitted QC: 2013-05-28
• Last Update Submitted: 2013-05-28
• Study First Posted: 2013-05-29
• Last Update Posted: 2013-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Amoxicillin and Tetracyclines	Amoxicillin and Tetracyclines	drug treatment
Mouth washing	Mouth washing	Mouth washing

Primary Outcome Measures

Name	Time	Method
Success Rate	12 months

Secondary Outcome Measures

Name	Time	Method
Diagnostic	6 months

Trial Locations

Locations (1)

Beijing University First Hospital; 🇨🇳 Beijiang, China