NCT05014334

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

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

• Helicobacter Pylori Infection
• Chronic Gastritis

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-03-31
• Completion: 2022-06-30
• First posted: 2021-08-20
• Last updated: 2023-01-31

Locations

1 site across 1 country: China