Effect of Oral Helicobacter Pylori Infection on the Efficacy of Gastroluminal Helicobacter Pylori Eradication Therapy

July 1, 2025 updated by: Yongquan Shi, Xijing Hospital of Digestive Diseases
The aim of this study is to assess the effect of oral Helicobacter pylori infection on the efficacy of gastric Helicobacter pylori infection eradication. Patients diagnosed with gastric Helicobacter pylori infection are tested for oral Helicobacter pylori and given standard bismuth quadruple therapy, with a urea breath test, a rapid urease test, or a Helicobacter pylori stool antigen test to confirm gastric Helicobacter pylori eradication at week 6 follow-up, and an oral Helicobacter pylori test kit to confirm oral Helicobacter pylori eradication.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hosipital of Digestive Disease

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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. Those who have contraindications to the drugs used in this institute or are allergic to the drugs used.
  2. There is serious organ damage and complications (such as cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
  3. 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).
  4. Those with severe oral diseases and malignant tumors of the mouth.
  5. Women planning pregnancy, pregnancy and breastfeeding.
  6. Previously had upper gastrointestinal surgery.
  7. Those who do not take their medication on time.
  8. Refusal to sign informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Both gastric and oral Helicobacter pylori are positive
Drug: Standard bismuth quadruple
Use the standard bismuth quadruple regimen recommended by the latest Chinese guidelines
Other: Positive for Helicobacter pylori for gastric and negative for Helicobacter pylori for oral cavity
Drug: Standard bismuth quadruple
Use the standard bismuth quadruple regimen recommended by the latest Chinese guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eradication rate of Helicobacter pylori in the stomach
Time Frame: 28 days after treatment
The primary end point of this study is to compare the rate of gastric Helicobacter pylori eradication in oral Helicobacter pylori positive and negative
28 days after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral Helicobacter pylori conversion rate
Time Frame: 28 days after treatment
Oral Helicobacter pylori conversion rate 28 days after treatment
28 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital of Digestive Diseases

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2022

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

March 17, 2023

First Submitted That Met QC Criteria

March 17, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

July 1, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20232027-C-1-B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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