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

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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Key information

Conditions

Helicobacter Pylori

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard bismuth quadruple

Drug

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

Primary outcomes

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

Secondary outcomes

Oral Helicobacter pylori conversion rate

Time frame: 28 days after treatment

Oral Helicobacter pylori conversion rate 28 days after treatment

Sponsors and collaborators

Lead sponsor

Xijing Hospital of Digestive Diseases

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Mar 30, 2023
Registry last updated: Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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