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Helicobacter Pylori Eradication and Follow-up

NCT ID: NCT05061732

Last Updated: 2021-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

4447 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2026-06-30

Brief Summary

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This randomized controlled clinical trial will estimate the eradication efficacy of different therapy for Helicobacter pylori treatment. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.

Detailed Description

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Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RBCL

Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, clarithromycin 0.5 g bid and levofloxacin 0.5 g qd for 14 days

Group Type EXPERIMENTAL

Rabeprazole

Intervention Type DRUG

20mg bid

Bismuth potassium citrate

Intervention Type DRUG

0.6g bid

Clarithromycin

Intervention Type DRUG

0.5g bid

Levofloxacin

Intervention Type DRUG

0.5g qd

RBLM

Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and levofloxacin 0.5 g bid for 14 days

Group Type EXPERIMENTAL

Rabeprazole

Intervention Type DRUG

20mg bid

Bismuth potassium citrate

Intervention Type DRUG

0.6g bid

Metronidazole

Intervention Type DRUG

0.4g qid

Levofloxacin

Intervention Type DRUG

0.5g qd

RBCM

Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and clarithromycin 0.5 g bid for 14 days

Group Type EXPERIMENTAL

Rabeprazole

Intervention Type DRUG

20mg bid

Bismuth potassium citrate

Intervention Type DRUG

0.6g bid

Metronidazole

Intervention Type DRUG

0.4g qid

Clarithromycin

Intervention Type DRUG

0.5g bid

RA

Rabeprazole 20 mg bid, and Amoxicillin 1.0 g tid for 14 days

Group Type EXPERIMENTAL

Rabeprazole

Intervention Type DRUG

20mg bid

Amoxicillin

Intervention Type DRUG

1g tid

RAB

Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, and Amoxicillin 1.0 g tid for 14 days

Group Type EXPERIMENTAL

Rabeprazole

Intervention Type DRUG

20mg bid

Bismuth potassium citrate

Intervention Type DRUG

0.6g bid

Amoxicillin

Intervention Type DRUG

1g tid

RAM

Rabeprazole 20 mg bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days

Group Type EXPERIMENTAL

Rabeprazole

Intervention Type DRUG

20mg bid

Metronidazole

Intervention Type DRUG

0.4g qid

Amoxicillin

Intervention Type DRUG

1g tid

RBAM

Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days

Group Type EXPERIMENTAL

Rabeprazole

Intervention Type DRUG

20mg bid

Bismuth potassium citrate

Intervention Type DRUG

0.6g bid

Metronidazole

Intervention Type DRUG

0.4g qid

Amoxicillin

Intervention Type DRUG

1g tid

RBAM4

Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and Amoxicillin 1.0 g tid for 14 days

Group Type EXPERIMENTAL

Rabeprazole

Intervention Type DRUG

20mg bid

Bismuth potassium citrate

Intervention Type DRUG

0.6g bid

Amoxicillin

Intervention Type DRUG

1g tid

Metronidazole

Intervention Type DRUG

0.4g tid

RBDM

Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and doxycycline 0.1 g bid for 14 days

Group Type EXPERIMENTAL

Rabeprazole

Intervention Type DRUG

20mg bid

Bismuth potassium citrate

Intervention Type DRUG

0.6g bid

Metronidazole

Intervention Type DRUG

0.4g tid

Doxycycline

Intervention Type DRUG

0.1g bid

RBTM

Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and tetracycline 0.5 g qid for 14 days

Group Type ACTIVE_COMPARATOR

Rabeprazole

Intervention Type DRUG

20mg bid

Bismuth potassium citrate

Intervention Type DRUG

0.6g bid

Metronidazole

Intervention Type DRUG

0.4g tid

Tetracycline

Intervention Type DRUG

0.5g qid

Interventions

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Rabeprazole

20mg bid

Intervention Type DRUG

Bismuth potassium citrate

0.6g bid

Intervention Type DRUG

Metronidazole

0.4g qid

Intervention Type DRUG

Clarithromycin

0.5g bid

Intervention Type DRUG

Levofloxacin

0.5g qd

Intervention Type DRUG

Amoxicillin

1g tid

Intervention Type DRUG

Metronidazole

0.4g tid

Intervention Type DRUG

Doxycycline

0.1g bid

Intervention Type DRUG

Tetracycline

0.5g qid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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, proton pump inhibitors 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Taotao Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qi Chen, MD

Role: CONTACT

Phone: 86-17811921405

Email: [email protected]

Facility Contacts

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Qi Chen, MD

Role: primary

Other Identifiers

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B2021-376

Identifier Type: -

Identifier Source: org_study_id