Treatment for Helicobacter Pylori Infection using a Quadruple Therapy

Study on the Efficacy and Safety of Berberine, Minocycline, Esomeprazole, and Colloidal Bismuth Quadruple Therapy in the Initial Treatment of Helicobacter Pylori.

This study is testing a new four-drug treatment for people with Helicobacter pylori infection to see if it works as well as the current options.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 548 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Xijing Hospital of Digestive Diseases (Academic / other)
• Locations: 1 site (Xian, Shaanxi)
• Trial ID: NCT06603688 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of a quadruple therapy that includes berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate for the initial treatment of Helicobacter pylori infection. Patients diagnosed with H. pylori will be randomly assigned to receive this treatment for 14 days, followed by a follow-up period to confirm eradication through various testing methods. The study aims to determine if this new therapy is as effective as existing treatments that include amoxicillin and clarithromycin.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with documented H. pylori infection and upper gastrointestinal symptoms who have not previously received eradication treatment.

Not a fit: Patients with severe organ damage, contraindications to the study drugs, or those who have recently used antibiotics or anti-ulcer medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and safer option for eradicating Helicobacter pylori infections.

How similar studies have performed: Other studies have shown success with similar quadruple therapies for H. pylori, but this specific combination is being evaluated for the first time.

Eligibility criteria

Inclusion Criteria:

1. Age between 18\~70,both gender.
2. Patients with upper gastrointestinal symptoms and with documented H.pylori infection who did not receive Helicobacter pylori eradication treatment;
3. Patients are willing to receive eradication treatment.
4. Women of childbearing age were required to use medically acceptable contraceptive methods during and 30 days after the trial.

Exclusion Criteria:

1. Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.
2. Patients with contraindications or allergies to the study drug.
3. Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
4. Constant use of anti-ulcer drugs ( including taking proton-pump.inhibitors(PPI) within 2 weeks before the \[13C\] urea breath test),antibiotics or bismuth complexes (more than 3 times /1 month before screening).
5. Patients were diagnosed with gastroduodenal ulcer and MALTlymphoma.
6. Pregnant or lactating women.
7. Underwent upper gastrointestinal Surgery.
8. Patients with moderate to severe dysplasia or high degree of intraepithelial neoplasia.
9. Patients have symptom of dysphagia.
10. Evidence of bleeding or iron efficiency anemia.
11. A history of malignancy.
12. Drug or alcohol abuse history in the past 1 year.
13. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs,anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
14. Patients who has psychological problem or poor compliance.
15. Enrolled in other clinical trials in the past 3 months.
16. Refuse to sign informed consent.

Where this trial is running

Xian, Shaanxi

• Xijing Hosipital of Digestive Disease — Xian, Shaanxi, China (Recruiting)

Study contacts

• Study coordinator: yongquan shi, Ph. D

Conditions Helicobacter Pylori Infection; Chronic Gastritis; Berberine; Bismuth; Helicobacter Pylori; Minocycline