Effect of Oral Helicobacter Pylori Infection on the Efficacy of Gastroluminal Helicobacter Pylori Eradication Therapy
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Eradication rate of Helicobacter pylori in the stomach
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Both gastric and oral Helicobacter pylori are positive
Intervention: Standard bismuth quadruple (Drug)
Positive for Helicobacter pylori for gastric and negative for Helicobacter pylori for oral cavity
Intervention: Standard bismuth quadruple (Drug)
Outcomes
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(28 days after treatment)
Investigators
Yongquan Shi
Principal Investigator, Clinical Professor
Xijing Hospital of Digestive Diseases