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

NCT06603688 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 548

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Helicobacter Pylori Infection
  • Chronic Gastritis

Interventions

DRUG

esomeprazole

Esomeprazole 40mg, twice daily for 14 days.

DRUG

Bismuth

Bismuth 220mg, twice daily for 14 days.

DRUG

Amoxicillin

Amoxicillin 1000mg, twice daily for 14 days.

DRUG

clarithromycin

clarithromycin 500mg, twice daily for 14 days.

DRUG

Berberine

Berberine 500 mg, twice daily for 14 days

DRUG

Minocycline

Minocycline 100 mg, twice daily for 14 days

Sponsors & Collaborators

  • Xijing Hospital of Digestive Diseases

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-20
Primary Completion
2024-11-01
Completion
2024-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06603688 on ClinicalTrials.gov