Status:
UNKNOWN
Bismuth-Metronidazole Triple Therapy for H. Pylori First-line Treatment
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This randomized controlled clinical trial will compare the eradication efficacy of bismuth-metronidazole triple therapy (PPI+bismuth+ metronidazole) with that of bismuth-metronidazole quadruple therap...
Eligibility Criteria
Inclusion
- Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
- 18-75 years old on the day of signing the ICF.
- Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.
- Have not received Helicobacter pylori eradication treatment before.
Exclusion
- Have received Hp eradication treatment.
- Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.
- Subjects or guardians refused to participate in the trial.
- Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.
- Have taken antibiotics, bismuth, PPI or Chinese traditional medicine 4 weeks before treatment.
- Pregnant or lactating women.
- Active peptic ulcer.
- allergic to drugs used in the trial.
- any other circumstances that are not suitable for recruitment.
Key Trial Info
Start Date :
December 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT04667299
Start Date
December 20 2020
End Date
December 31 2021
Last Update
December 22 2020
Active Locations (1)
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1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032