Effects of High-dose Dual Therapy and Bismuth Quadruple Therapy for Helicobacter Pylori Eradication on Intestinal Microecology

Launched by XIJING HOSPITAL OF DIGESTIVE DISEASES · Feb 14, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring how two different treatment methods can help eliminate a common stomach infection called Helicobacter pylori (H. pylori). The researchers want to see how these treatments affect the balance of bacteria in the intestines, which is important for overall gut health. They will look at changes in the variety and composition of gut bacteria before and after treatment, helping to understand any potential side effects or drug resistance issues that may arise from these therapies.

To participate in this study, you need to be between 18 and 70 years old and have a confirmed H. pylori infection without having previously received treatment for it. Women who can become pregnant must agree to use reliable birth control during the study. If you join, you can expect to receive one of the two treatment methods and will be asked to provide samples to track how your gut bacteria change over time. It's important to note that there are specific health conditions and treatments that could exclude you from participating, so discussing your medical history with the study team will be essential.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 to 70 years, regardless of gender.
• • 2. Patients with definite Hp infection (positive for either 13C/14C urea breath test, rapid urease test, and fecal Hp antigen test) and who have not received H. pylori eradication therapy.
• • 3. Voluntary Hp eradication therapy.
• • 4. Women of childbearing potential are required to use a medically advisable form of contraception during the trial and for 30 days after the trial ends.
• Exclusion Criteria:
• • 1. Patients who have had a definite diagnosis of Hp infection and have been treated with antibiotic eradication therapy.
• • 2. Patients with contraindications to or allergies to the study drug.
• • 3. Patients with severe organ damage and complications (e.g., cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine disease
• • 4. Continuous use of anti-ulcer drugs, antibiotics or bismuth complexes (taken at least 2 weeks prior to the screening for Hp infection)
• • 5. Pregnant and lactating women.
• • 6. Having undergone upper gastrointestinal surgery.
• • 7. Have symptoms of dysphagia.
• • 8. Evidence of bleeding or iron deficiency anemia.
• • 9. History of malignancy.
• • 10. History of drug or alcohol abuse within the last 1 year.
• • 11. Systemic application of glucocorticoids, non-steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except for the use of aspirin ≤100 mg/d)
• • 12. Those with psychiatric disorders.
• • 13. Received other clinical trials within the past 3 months
• • 14. Refusal to sign the informed consent form.