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

Xijing Hospital of Digestive Diseases548 enrolled

Overview

The aim of this study is to evaluate the efficacy and safety of a quadruple therapy consisting of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate for the first phase eradication of Helicobacter pylori. Assuming that the quadruple therapy of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate is no less effective than the bismuth containing quadruple therapy of amoxicillin and clarithromycin. Patients diagnosed with Helicobacter pylori infection will be randomly assigned to one of the aforementioned treatments. During the 6-week follow-up, urea breath test, rapid urease test, or Helicobacter pylori fecal antigen test will be performed to confirm eradication. The aim of this study is to evaluate the efficacy and safety of a quadruple therapy consisting of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate for the first phase eradication of Helicobacter pylori. Assuming that the quadruple therapy of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate is no less effective than the bismuth containing quadruple therapy of amoxicillin and clarithromycin. Patients diagnosed with Helicobacter pylori infection will be randomly assigned to one of the aforementioned treatments. During the 6-week follow-up, urea breath test, rapid urease test, or Helicobacter pylori fecal antigen test will be performed to confirm eradication.

Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. One of urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations. Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 13 and 17. Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test，rapid urease test or helicobacter pylori stool antigen test.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Interventions

esomeprazoleDRUG

Esomeprazole 40mg, twice daily for 14 days.

BismuthDRUG

Bismuth 220mg, twice daily for 14 days.

AmoxicillinDRUG

Amoxicillin 1000mg, twice daily for 14 days.

clarithromycinDRUG

clarithromycin 500mg, twice daily for 14 days.

BerberineDRUG

Berberine 500 mg, twice daily for 14 days

MinocyclineDRUG

Minocycline 100 mg, twice daily for 14 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

H pylori eradication rates

The primary end point of this study is H.pylori eradication,established by negative urea breath test，rapid urease test or helicobacter pylori stool antigen test 28 days after the end of treatment.

Time frame: 28 days after treatment

Secondary Outcomes

symptoms effective rate

Evaluation effective rate of symptoms 2 weeks of treatment and 4 weeks after the end of treatment. Symptom effective rate =（total score before treatment - total score after treatment）/total score before treatment x 100%. Total score = frequency + severity. Frequency score is calculated by all the frequency of heartburn, reflux, abdominal pain, and flatulence. Severity is accumulated by the degree of symptoms described above, which is divided to 4 degree as 0 presenting none, and 3 presenting most severe

Time frame: 14 days of treatment, and 28 days after treatment