Effects of high-dose dual therapy and bismuth quadruple therapy on H. pylori eradication and gut health

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

This study tests whether two different treatments for H. pylori can not only get rid of the infection but also improve gut health in patients.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Xijing Hospital of Digestive Diseases (Academic / other)
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT05742568 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of high-dose dual therapy and bismuth quadruple therapy on eradicating Helicobacter pylori and its effects on intestinal microecology. Patients diagnosed with H. pylori infection will be randomly assigned to one of the two treatment regimens for two weeks. The study will assess changes in intestinal microbiota diversity and structure before and after treatment through stool samples analyzed via 16S rRNA gene sequencing. The findings aim to enhance understanding of the relationship between H. pylori treatment and gut microbiota health.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with a confirmed H. pylori infection who have not previously undergone eradication therapy.

Not a fit: Patients with severe organ damage, those who have previously received H. pylori treatment, or those with contraindications to the study drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment strategies for H. pylori infection and enhance gut health.

How similar studies have performed: Other studies have shown promising results with similar therapeutic approaches, indicating potential for success in this trial.

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.

Where this trial is running

Xi'an, Shaanxi

• Xijing Hosipital of Digestive Disease — Xi'an, Shaanxi, China (Recruiting)

Study contacts

• Study coordinator: Tengteng Wang

Conditions Gastritis; Dyspepsia; Helicobacter Pylori Infection; Gastric Cancer; Peptic Ulcer; Helicobacter pylori; High-dose dual therapy; Bismuth-combining quadruple therapy