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

• Status: Recruiting
• Trial end date: 2024-03-10
• Target enrollment: 0
• Participant gender: All

Summary

This study was conducted to investigate the effects of high-dose diphtherapy and bismuth quadruple therapy on H. pylori eradication on intestinal microecology, to clarify the changes in intestinal microbiota diversity and structure before and after the two treatment regimens, and to explore the relationship between different treatment regimens and intestinal microbiota dysbiosis; to further guide the safety and drug resistance of H. pylori eradication by the two treatment regimens. The expected results are to observe the changes of intestinal microbiota diversity and structure before and after treatment with the two treatment regimens.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xijing Hospital of Digestive Diseases
• Treatments: Amoxicillin; Bismuth; Clarithromycin; Esomeprazole

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.