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Rescue Therapy for Helicobacter Pylori Eradication Treatment

NCT ID: NCT04531059

Last Updated: 2024-12-30

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

368 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2022-12-31

Brief Summary

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Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy in which tetracycline was replaced by minocycline.

Detailed Description

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Conditions

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Helicobacter Pylori Infection

Keywords

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Helicobacter pylori rescue therapy minocycline tetracycline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tetracycline Bismuth Quadruple Therapy

Esomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Tetracycline 500mg qid Metronidazole 400mg qid

Group Type ACTIVE_COMPARATOR

Esomeprazole

Intervention Type DRUG

Proton pump inhibitor

Bismuth Potassium Citrate

Intervention Type DRUG

Gastric mucosal protective drug with anti-H. pylori effect

Tetracycline,Metronidazole

Intervention Type DRUG

Antibiotics for H. pylori eradication

Minocycline Bismuth Quadruple Therapy

Esomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Minocycline 100mg bid Metronidazole 400mg qid

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

Proton pump inhibitor

Bismuth Potassium Citrate

Intervention Type DRUG

Gastric mucosal protective drug with anti-H. pylori effect

Minocycline,Metronidazole

Intervention Type DRUG

Antibiotics for H. pylori eradication

Interventions

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Esomeprazole

Proton pump inhibitor

Intervention Type DRUG

Bismuth Potassium Citrate

Gastric mucosal protective drug with anti-H. pylori effect

Intervention Type DRUG

Tetracycline,Metronidazole

Antibiotics for H. pylori eradication

Intervention Type DRUG

Minocycline,Metronidazole

Antibiotics for H. pylori eradication

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Ability and willingness to participate in the study and to sign and give informed consent
* Confirmed H. pylori infection and with previous treatment failure

Exclusion Criteria

* subjects naive to H. pylori treatment,
* under 18 or over 80 years old
* history of gastrectomy
* pregnant or lactating women
* severe systemic diseases or malignancy
* administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks
* contraindications to the study drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Hong Lu, MD

Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai East Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status

The Second Affiliated Hospital of Zhejiang University school of Medicine

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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rjkls2019013

Identifier Type: -

Identifier Source: org_study_id