Study on the Efficacy and Safety of Berberine, Minocycline, Esomeprazole, and Colloidal Bismuth Quadruple Therapy in the Initial Treatment of Helicobacter Pylori.

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

The aim of this study is to evaluate the efficacy and safety of a quadruple therapy consisting of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate for the first phase eradication of Helicobacter pylori. Assuming that the quadruple therapy of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate is no less effective than the bismuth containing quadruple therapy of amoxicillin and clarithromycin. Patients diagnosed with Helicobacter pylori infection will be randomly assigned to one of the aforementioned treatments. During the 6-week follow-up, urea breath test, rapid urease test, or Helicobacter pylori fecal antigen test will be performed to confirm eradication. The aim of this study is to evaluate the efficacy and safety of a quadruple therapy consisting of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate for the first phase eradication of Helicobacter pylori. Assuming that the quadruple therapy of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate is no less effective than the bismuth containing quadruple therapy of amoxicillin and clarithromycin. Patients diagnosed with Helicobacter pylori infection will be randomly assigned to one of the aforementioned treatments. During the 6-week follow-up, urea breath test, rapid urease test, or Helicobacter pylori fecal antigen test will be performed to confirm eradication.

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

• 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.

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: 2023-11-20
Estimated Completion Date: 2024-12-01
Participants
Target number of participants: 548
Treatments
Experimental: experimental group:Minocycline+Berberine quadruple therapy
40mg of esomeprazole, 220mg of colloidal bismuth tartrate, 500mg of berberine hydrochloride, and 100mg of minocycline, taken orally twice daily for 14 days.
Active_comparator: control group:Amoxicillin+clarithromycin quadruple
40mg of esomeprazole, 220mg of bismuth tartrate colloid, 500mg of clarithromycin, and 1000mg of amoxicillin, taken orally twice a day for 14 days.
Sponsors
Leads: Xijing Hospital of Digestive Diseases

This content was sourced from clinicaltrials.gov

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