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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05790525
Enrollment
200
Registered
2023-03-30
Start date
2022-11-22
Completion date
2023-11-01
Last updated
2025-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori

Keywords

Oral Helicobacter pylori, Helicobacter pylori gastric, Eradication rate of Helicobacter pylori in the stomach

Brief summary

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.

Interventions

DRUGStandard bismuth quadruple

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

Sponsors

Xijing Hospital of Digestive Diseases
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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. 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.

Design outcomes

Primary

MeasureTime frameDescription
Eradication rate of Helicobacter pylori in the stomach28 days after treatmentThe primary end point of this study is to compare the rate of gastric Helicobacter pylori eradication in oral Helicobacter pylori positive and negative

Secondary

MeasureTime frameDescription
Oral Helicobacter pylori conversion rate28 days after treatmentOral Helicobacter pylori conversion rate 28 days after treatment

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026