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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01863823
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : May 29, 2013
Sponsor:
Information provided by (Responsible Party):
K C Yee, Ameritek USA

Tracking Information
First Submitted Date  ICMJE May 10, 2013
First Posted Date  ICMJE May 29, 2013
Last Update Posted Date May 29, 2013
Study Start Date  ICMJE August 2011
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2013)
Success Rate [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2013)
Diagnostic [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 28, 2013)
Agreement of diagnostic and success rate of gastric eradication [ Time Frame: 12 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effective Treatment of Oral Helicobacter Pylori With the Success Rate of Gastric Eradication
Official Title  ICMJE Director of Research Division
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Oral Helicobacter Pylori
Intervention  ICMJE
  • 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 Name: dBest
  • Drug: Mouth washing
    Two time washing mouth per day
    Other Name: dBest
Study Arms  ICMJE
  • Amoxicillin and Tetracyclines
    drug treatment
    Intervention: Drug: Amoxicillin and Tetracyclines
  • Mouth washing
    Mouth washing
    Intervention: Drug: Mouth washing
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 28, 2013)
350
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01863823
Other Study ID Numbers  ICMJE AmeritekUsa
Ameritek USA ( Registry Identifier: Ameritek USA )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party K C Yee, Ameritek USA
Study Sponsor  ICMJE Ameritek USA
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ameritek USA
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP