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

Study Overview
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Brief Summary
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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.

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

Conditions
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Helicobacter Pylori

Intervention / Treatment
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* Drug: Standard bismuth quadruple


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 70 ,both gender. Initial diagnosis of stomach Helicobacter pylori infection or never had Helicobacter pylori infection. Have not received dental care or systemic periodontal basic treatment in the past 1 year. Exclusion Criteria: Those who have contraindications to the drugs used in this institute or are allergic to the drugs used. There is serious organ damage and complications (such as cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases. 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). Those with severe oral diseases and malignant tumors of the mouth. Women planning pregnancy, pregnancy and breastfeeding. Previously had upper gastrointestinal surgery. Those who do not take their medication on time. Refusal to sign informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate of Helicobacter pylori in the stomach | 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 | Oral Helicobacter pylori conversion rate 28 days after treatment | 28 days after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Helicobacter pylori, Helicobacter pylori gastric, Eradication rate of Helicobacter pylori in the stomach