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

NCT05014334 | Completed Phase 4

• 1 other identifier: KY20212155-C-1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection; Chronic Gastritis

Keywords

Berberine; Bismuth; vonoprazan; Helicobacter Pylori

Outcome Measures

Primary Outcomes (1)

• 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.

  28 days after treatment

Secondary Outcomes (2)

• symptoms effective rate

  14 days of treatment, and 28 days after treatment

• adverse events

  14 days of treatment, and 28 days after treatment

Study Arms (3)

Berberine-containing triple therapy

EXPERIMENTAL

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

Drug: Berberine; Drug: Vonoprazan; Drug: Amoxicillin

Bismuth-containing quadruple therapy

ACTIVE COMPARATOR

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

Drug: Amoxicillin; Drug: Rabeprazole; Drug: Bismuth; Drug: Clarithromycin

vonoprazan-containing quadruple therapy

ACTIVE COMPARATOR

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

Drug: Vonoprazan; Drug: Amoxicillin; Drug: Bismuth; Drug: Clarithromycin

Interventions

Berberine DRUG

berberine 500 mg, twice daily for 14 days

Berberine-containing triple therapy

Vonoprazan DRUG

Vonoprazan 20 mg, twice daily for 14 days

Berberine-containing triple therapy; vonoprazan-containing quadruple therapy

Amoxicillin DRUG

amoxicillin 1000mg, twice daily for 14 days.

Berberine-containing triple therapy; Bismuth-containing quadruple therapy; vonoprazan-containing quadruple therapy

Rabeprazole DRUG

Rabeprazole 10mg, twice daily for 14 days.

Bismuth-containing quadruple therapy

Bismuth DRUG

Bismuth 220mg, twice daily for 14 days.

Bismuth-containing quadruple therapy; vonoprazan-containing quadruple therapy

Clarithromycin DRUG

clarithromy 500mg, twice daily for 14 days.

Bismuth-containing quadruple therapy; vonoprazan-containing quadruple therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Interventions

Berberine; 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Amoxicillin; Rabeprazole; Bismuth; Clarithromycin

Intervention Hierarchy (Ancestors)

Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles; Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Radioisotopes; Isotopes; Metals; Erythromycin; Macrolides; Polyketides; Lactones

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: August 20, 2021
• Study Start: December 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: June 30, 2022
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)