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

Sponsor

Xijing Hospital of Digestive Diseases (Other)

Overall Status

Recruiting

CT.gov ID

NCT05014334

Collaborator

(none)

300

Enrollment

Location

Arms

6.9

Anticipated Duration (Months)

43.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection Chronic Gastritis	Drug: Berberine Drug: Vonoprazan Drug: Amoxicillin Drug: Rabeprazole Drug: Bismuth Drug: Clarithromycin	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Study on The Efficacy and Safety of Berberine,Amoxicillin and Vonoprazan Containing Triple Therapy in Helicobacter Pylori First-Line Eradication

Anticipated Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Berberine-containing triple therapy vonoprazan 20 mg , amoxicillin 1000 mg , and berberine 500 mg by mouth,twice daily for 14 days.	Drug: Berberine berberine 500 mg, twice daily for 14 days Drug: Vonoprazan Vonoprazan 20 mg, twice daily for 14 days Drug: Amoxicillin amoxicillin 1000mg, twice daily for 14 days.
Active Comparator: 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.	Drug: Amoxicillin amoxicillin 1000mg, twice daily for 14 days. Drug: Rabeprazole Rabeprazole 10mg, twice daily for 14 days. Drug: Bismuth Bismuth 220mg, twice daily for 14 days. Drug: Clarithromycin clarithromy 500mg, twice daily for 14 days.
Active Comparator: 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.	Drug: Vonoprazan Vonoprazan 20 mg, twice daily for 14 days Drug: Amoxicillin amoxicillin 1000mg, twice daily for 14 days. Drug: Bismuth Bismuth 220mg, twice daily for 14 days. Drug: Clarithromycin clarithromy 500mg, twice daily for 14 days.

Arm

Intervention/Treatment

Experimental: Berberine-containing triple therapy

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

Drug: Berberine

berberine 500 mg, twice daily for 14 days

Drug: Vonoprazan

Vonoprazan 20 mg, twice daily for 14 days

Drug: Amoxicillin

amoxicillin 1000mg, twice daily for 14 days.

Active Comparator: 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.

Drug: Amoxicillin

amoxicillin 1000mg, twice daily for 14 days.

Drug: Rabeprazole

Rabeprazole 10mg, twice daily for 14 days.

Drug: Bismuth

Bismuth 220mg, twice daily for 14 days.

Drug: Clarithromycin

clarithromy 500mg, twice daily for 14 days.

Active Comparator: 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.

Drug: Vonoprazan

Vonoprazan 20 mg, twice daily for 14 days

Drug: Amoxicillin

amoxicillin 1000mg, twice daily for 14 days.

Drug: Bismuth

Bismuth 220mg, twice daily for 14 days.

Drug: Clarithromycin

clarithromy 500mg, twice daily for 14 days.

Outcome Measures

Primary Outcome Measures

H pylori eradication rates [28 days after treatment]
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.

Secondary Outcome Measures

symptoms effective rate [14 days of treatment, and 28 days after treatment]
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
adverse events [14 days of treatment, and 28 days after treatment]
Participants with Adverse Events as a Measure of Safety and Tolerability.The common side effects of the study include headache, dizziness, skin rash, other gastrointestinal disorders, pyrexia, cough and back pain.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.
Patients with contraindications or allergies to the study drug.
Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
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).
Patients were diagnosed with gastroduodenal ulcer and MALTlymphoma.
Pregnant or lactating women.
Underwent upper gastrointestinal Surgery.
Patients with moderate to severe dysplasia or high degree of intraepithelial neoplasia.
Patients have symptom of dysphagia.
Evidence of bleeding or iron efficiency anemia.
A history of malignancy.
Drug or alcohol abuse history in the past 1 year.
Systemic use of corticosteroids, non steroidal anti-inflammatory drugs,anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
Patients who has psychological problem or poor compliance.
Enrolled in other clinical trials in the past 3 months.
Refuse to sign informed consent.