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Association of Oral Helicobacter Pylori Infection With Gastric Helicobacter Pylori Infection

Sponsor
Xijing Hospital of Digestive Diseases (Other)
Overall Status
Recruiting
CT.gov ID
NCT05790512
Collaborator
(none)
500
Enrollment
1
Location
11.3
Anticipated Duration (Months)
44.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study was to investigate the association between oral Helicobacter pylori infection and gastric Helicobacter pylori infection. Patients who were tested for gastric Helicobacter pylori were tested for oral Helicobacter pylori at the same time, and were divided into four groups according to the test results to compare the positive rate of oral Helicobacter pylori.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Association of Oral Helicobacter Pylori Infection With Gastric Helicobacter Pylori Infection
    Actual Study Start Date :
    Nov 22, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Nov 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Both gastric and oral Helicobacter pylori are negative
    Negative for Helicobacter pylori for gastric and positive for Helicobacter pylori for oral cavity
    Positive for Helicobacter pylori for gastric and negative for Helicobacter pylori for oral cavity
    Both gastric and oral Helicobacter pylori are positive

    Outcome Measures

    Primary Outcome Measures

    1. Positive rate of oral Helicobacter pylori [7 months]

      The oral Helicobacter pylori test is performed using the Helicobacter pylori test kit

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Age between 18~70 ,both gender.

    2. Initial diagnosis of stomach Helicobacter pylori infection or never had Helicobacter pylori infection.

    3. Have not received dental care or systemic periodontal basic treatment in the past 1 year.

    Exclusion Criteria:

    1. There is serious organ damage and complications (such as cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.

    2. Ongoing use of antiulcer medications (including PPIs taken within 2 weeks before Helicobacter pylori infection testing), antibiotics, or bismuth complexes (more than 3 times/week before screening).

    3. Those with severe oral diseases and malignant tumors of the mouth.

    4. Previously had upper gastrointestinal surgery.

    5. Refusal to sign informed consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xijing Hosipital of Digestive Disease Xi'an Shaanxi China 710032

    Sponsors and Collaborators

    • Xijing Hospital of Digestive Diseases

    Investigators

    • Study Director: Yongquan Shi, PhD, Xijing Hosipital of Digestive Disease

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yongquan Shi, Principal Investigator, Clinical Professor, Xijing Hospital of Digestive Diseases
    ClinicalTrials.gov Identifier:
    NCT05790512
    Other Study ID Numbers:
    • KY20232027-C-1-A
    First Posted:
    Mar 30, 2023
    Last Update Posted:
    Mar 30, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yongquan Shi, Principal Investigator, Clinical Professor, Xijing Hospital of Digestive Diseases
    Oral Helicobacter Pylori
    Helicobacter Pylori Gastric
    Additional relevant MeSH terms:
    Infections

    Study Results

    No Results Posted as of Mar 30, 2023