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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-22

Study Completion Date

2023-11-01

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.

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Detailed Description

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Conditions

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Helicobacter Pylori

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Both gastric and oral Helicobacter pylori are positive

Group Type OTHER

Standard bismuth quadruple

Intervention Type DRUG

Use the standard bismuth quadruple regimen recommended by the latest Chinese guidelines

Positive for Helicobacter pylori for gastric and negative for Helicobacter pylori for oral cavity

Group Type OTHER

Standard bismuth quadruple

Intervention Type DRUG

Use the standard bismuth quadruple regimen recommended by the latest Chinese guidelines

Interventions

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Standard bismuth quadruple

Use the standard bismuth quadruple regimen recommended by the latest Chinese guidelines

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes