Study on The Efficacy and Safety of Berberine-containing Triple Therapy in Helicobacter Pylori First-Line Eradication

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-06-30

Brief Summary

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The purpose of this study is to assess the efficacy and safety of berberine, amoxicillin and vonoprazan containing triple therapy in Helicobacter Pylori first-line eradication. It is hypothesized that berberine hydrochloride, amoxicillin and vonoprazan triple therapy is non-inferior to bismuth-containing quadruple therapy or vonoprazan -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.

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Detailed Description

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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

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Helicobacter Pylori Infection Chronic Gastritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Berberine-containing triple therapy

vonoprazan 20 mg , amoxicillin 1000 mg , and berberine 500 mg by mouth,twice daily for 14 days.

Group Type EXPERIMENTAL

Berberine

Intervention Type DRUG

berberine 500 mg, twice daily for 14 days

Vonoprazan

Intervention Type DRUG

Vonoprazan 20 mg, twice daily for 14 days

Amoxicillin

Intervention Type DRUG

amoxicillin 1000mg, twice daily for 14 days.

Bismuth-containing quadruple therapy

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

Group Type ACTIVE_COMPARATOR

Amoxicillin

Intervention Type DRUG

amoxicillin 1000mg, twice daily for 14 days.

Rabeprazole

Intervention Type DRUG

Rabeprazole 10mg, twice daily for 14 days.

Bismuth

Intervention Type DRUG

Bismuth 220mg, twice daily for 14 days.

Clarithromycin

Intervention Type DRUG

clarithromy 500mg, twice daily for 14 days.

vonoprazan-containing quadruple therapy

Bismuth potassium citrate 220 mg, vonoprazan 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.

Group Type ACTIVE_COMPARATOR

Vonoprazan

Intervention Type DRUG

Vonoprazan 20 mg, twice daily for 14 days

Amoxicillin

Intervention Type DRUG

amoxicillin 1000mg, twice daily for 14 days.

Bismuth

Intervention Type DRUG

Bismuth 220mg, twice daily for 14 days.

Clarithromycin

Intervention Type DRUG

clarithromy 500mg, twice daily for 14 days.

Interventions

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Berberine

berberine 500 mg, twice daily for 14 days

Intervention Type DRUG

Vonoprazan

Vonoprazan 20 mg, twice daily for 14 days

Intervention Type DRUG

Amoxicillin

amoxicillin 1000mg, twice daily for 14 days.

Intervention Type DRUG

Rabeprazole

Rabeprazole 10mg, twice daily for 14 days.

Intervention Type DRUG

Bismuth

Bismuth 220mg, twice daily for 14 days.

Intervention Type DRUG

Clarithromycin

clarithromy 500mg, twice daily for 14 days.

Intervention Type DRUG

Eligibility Criteria

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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

Yes