Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradication: A Prospective, Randomized Controlled Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This study aims to evaluate the efficacy of vonoprazan combined with different antibiotics in dual therapy for Helicobacter pylori eradication treatment. Newly infected patients were randomly assigned to four groups: amoxicillin dual therapy, tetracycline dual therapy, minocycline dual therapy, and bismuth quadruple therapy. At the follow - up visit in the 6th week, urea breath test, rapid urease test, or Helicobacter pylori fecal antigen test will be conducted to confirm eradication.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Aged 18 - 70 years, regardless of gender;

• Patients with definite Hp infection (positive result in any one of the 13C/14C urea breath test, rapid urease test, and fecal Hp antigen test) who have never received Helicobacter pylori eradication treatment;

• For women of child - bearing age, it is required to use medically acceptable contraceptive methods during the trial period and within 30 days after the end of the trial.

Locations
Other Locations
China
Xijing Hosipital of Digestive Disease
RECRUITING
Xi'an
Contact Information
Primary
Yongquan Shi, Ph. D
shiyquan@fmmu.edu.cn
86-29-84771515
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 400
Treatments
Experimental: Vonoprazan - amoxicillin dual therapy
Vonorazon 20 mg daily for 14 days # amoxicillin 1000 mg by mouth three time daily for 14 days
Experimental: Vonoprazan-tetracycline dual therapy
Vonorazon 20 mg daily for 14 days # tetracycline 500 mg by mouth three time daily for 14 days
Experimental: Vonoprazan-minocycline dual therapy
Vonorazon 20 mg daily for 14 days # minocycline 100 mg by mouth two time daily for 14 days
Active_comparator: Bismuth-containing quadruple therapy
Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days
Sponsors
Leads: Yongquan Shi

This content was sourced from clinicaltrials.gov