Helicobacter Pylori Eradication With Berberine Plus Amoxicillin Triple Therapy Versus Bismuth-containing Quadruple Therapy

NCT ID: NCT04697186

Last Updated: 2023-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 524 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-07
• Study Completion Date: 2021-12-20

Brief Summary

This study aims at evaluating efficacy and safety of berberine hydrochloride, amoxicillin and rabeprazole triple therapy versus bismuth-containing quadruple therapy(amoxicillin, clarithromycin, rabeprazole and bismuth) in the first eradication treatment of H. pylori. It is hypothesized that berberinehydrochloride, amoxicillin and rabeprazole triple therapy is non-inferior to bismuth-containing quadruple therapy. Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. At week 6 follow-up visits, a urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.

Detailed Description

Detailed Description:

The study will include three phases: screening, treatment and follow-up. 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.

Conditions

Dyspepsia; Chronic Gastritis; Gastric Cancer; Helicobacter Pylori Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

berberine , amoxicillin and rabeprazole triple therapy

Berberine 300mg three time daily for 14days, amoxicillin 1000 mg and rabeprazole 10 mg by mouth, twice daily for 14 days.

Group Type: EXPERIMENTAL

Berberine

Intervention Type: DRUG

berberine , amoxicillin and rabeprazole triple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，rabeprazole 10 mg BID.

Amoxicillin

Intervention Type: DRUG

berberine , amoxicillin and rabeprazole triple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，rabeprazole 10 mg BID.

Rabeprazole

Intervention Type: DRUG

berberine , amoxicillin and rabeprazole triple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，rabeprazole 10 mg BID.

Bismuth-containing Quadruple Therapy

amoxicillin 1000 mg，clarithromy 500mg，rabeprazole 10 mg, and Bismuth 220mg by mouth, twice daily for 14 days.

Group Type: ACTIVE_COMPARATOR

Amoxicillin

Intervention Type: DRUG

Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID

Clarithromycin

Intervention Type: DRUG

Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID

Rabeprazole

Intervention Type: DRUG

Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID

Bismuth

Intervention Type: DRUG

Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID

Interventions

Berberine

berberine , amoxicillin and rabeprazole triple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，rabeprazole 10 mg BID.

Intervention Type: DRUG

Amoxicillin

berberine , amoxicillin and rabeprazole triple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，rabeprazole 10 mg BID.

Intervention Type: DRUG

Rabeprazole

berberine , amoxicillin and rabeprazole triple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，rabeprazole 10 mg BID.

Intervention Type: DRUG

Amoxicillin

Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID

Intervention Type: DRUG

Clarithromycin

Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID

Intervention Type: DRUG

Rabeprazole

Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID

Intervention Type: DRUG

Bismuth

Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID

Intervention Type: DRUG

Other Intervention Names

Amoxy; Pariet; Amoxy; Krashen; Pariet

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital of Digestive Diseases

OTHER

Sponsor Role: lead

Responsible Party

Yongquan Shi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

KY20202119

Identifier Type: -

Identifier Source: org_study_id