Overview

Helicobacter Pylori Eradication With Berberine Quadruple Therapy Versus Clarithromycin Quadruple Therapy

Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
0
Participant gender:
All
Summary
This study aims at evaluating efficacy and safety of berberine-containing quadruple therapy(berberine, lansoprazole, bismuth and amoxicillin) versus clarithromycin-containing quadruple therapy (clarithromycin,lansoprazole, bismuth and amoxicillin) in H. pylori eradication. It is hypothesized that berberine-containing quadruple therapy is non-inferior to clarithromycin-containing quadruple therapy. Patients with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 2 and 6 follow-up visits, a urea breath test(UBT) will be performed to confirm eradication.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Xijing Hospital of Digestive Diseases
Treatments:
Amoxicillin
Bismuth
Clarithromycin
Dexlansoprazole
Lansoprazole
Criteria
Inclusion Criteria:

1. Age between 18~70,both gender.

2. Patients with upper gastrointestinal symptoms and with documented H.pylori infection.

3. Patients are willing to receive eradication treatment.

4. Women are eligible if they are not pregnant or nursing, and if they are of
childbearing potential they are required to use medically acceptable contraception for
the duration of the study and 30 days thereafter.

Exclusion Criteria:

1. Patients are excluded if they have previously used antibiotics to eradicate adequately
recorded infection with H. pylori.

2. Contraindications to study drugs.

3. Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.

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. Pregnant or lactating women.

6. Underwent upper gastrointestinal Surgery.

7. Patients with Barrett esophageal or highly atypical hyperplasia, have symptom of
dysphagia.

8. Evidence of bleeding or iron efficiency anemia.

9. A history of malignancy.

10. Drug or alcohol abuse history in the past 1 year.

11. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs,
anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less
than 100 mg/d).

12. Enrolled in other clinical trials in the past 3 months.