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

Sponsor
Ameritek USA (Industry)
Overall Status
Completed
CT.gov ID
NCT01863823
Collaborator
(none)
350
Enrollment
1
Location
2
Arms
13
Duration (Months)
26.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Amoxicillin and Tetracyclines
  • Drug: Mouth washing
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Director of Research Division
Study Start Date :
Aug 1, 2011
Actual Primary Completion Date :
Sep 1, 2012
Actual Study Completion Date :
Sep 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Other: Amoxicillin and Tetracyclines

drug treatment

Drug: Amoxicillin 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.
Other Names:
  • dBest

    		•
    Other: Mouth washing

    Mouth washing

    Drug: Mouth washing
    Two time washing mouth per day
    Other Names:
  • dBest

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Success Rate [12 months]

    Secondary Outcome Measures

    1. Diagnostic [6 months]

    Other Outcome Measures

    1. Agreement of diagnostic and success rate of gastric eradication [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing University First Hospital Beijiang China 1001

    Sponsors and Collaborators

    • Ameritek USA

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    K C Yee, Director of Research Division, Ameritek USA
    ClinicalTrials.gov Identifier:
    NCT01863823
    Other Study ID Numbers:
    • AmeritekUsa
    • Ameritek USA
    First Posted:
    May 29, 2013
    Last Update Posted:
    May 29, 2013
    Last Verified:
    May 1, 2013
    Keywords provided by K C Yee, Director of Research Division, Ameritek USA
    Symptomatic patients
    asymptomatic individuals
    clinical trial
    Additional relevant MeSH terms:
    Amoxicillin
    Tetracycline

    Study Results

    No Results Posted as of May 29, 2013