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

KY20232027-C-1-B

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.

2022-11-22

2023-09-01

2023-11-01

Recruiting

Early phase I

200

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2023-08-04