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High-dose Dual Therapy and Minocycline-cotaining Quadruple Therapy for Helicobacter Pylori Infection

NCT ID: NCT06561698

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

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-21

Study Completion Date

2026-08-30

Brief Summary

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This study is a multicentra, prospective study. The enrolled patients are HP positive. They are diagnosed as HP positive by rapid urease test and/or 13C urea breath test. According to the declaration of Helsinki, 200 patients will be included in this study. After obtaining the written informed consent of the patients, HP culture and drug sensitivity test will be conducted on all the selected patients with the success rate, adverse reactions, compliance, antibiotic resistance of HP and its impact on HP eradication.

Detailed Description

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Conditions

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Helicobacter Pylori Infection

Keywords

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Helicobacter pylori minocycline amoxicillin

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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Dual therapy

Group Type EXPERIMENTAL

Vonoprazan

Intervention Type DRUG

Potassium competitive acid blocker

Amoxicillin

Intervention Type DRUG

Antibiotics for H. pylori eradication

Minocycline bismush quadruple therapy

Group Type EXPERIMENTAL

Vonoprazan

Intervention Type DRUG

Potassium competitive acid blocker

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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Vonoprazan

Potassium competitive acid blocker

Intervention Type DRUG

Amoxicillin

Antibiotics for H. pylori eradication

Intervention Type DRUG

Bismuth Potassium Citrate

Gastric mucosal protective drug with anti-H. pylori effect

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

Exclusion Criteria

* Pregnant and lactating women;
* History of gastrointestinal malignancies;
* History of previous subtotal gastrectomy;
* Serious dysfunction of heart, liver, kidney, lung and other important organs and congenital diseases; Such as grade IV cardiac insufficiency, liver failure, uremia, respiratory failure, hemophilia, Wilson disease, etc;
* History of hematological diseases
* People who are allergic to drugs;
* The guardian or patient refused to join the group;
* Alcohol and / or drug abuse (addiction or dependence) or poor compliance judged by doctors;
* No legal capacity or poor self-knowledge
* administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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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Hebi People's Hospital

Hebi, Henan, China

Site Status RECRUITING

Jiaozuo People's Hospital

Jiaozuo, Henan, China

Site Status RECRUITING

Luoyang central Hospital

Luoyang, Henan, China

Site Status RECRUITING

The first people's hospital of ping ding shan

Pingdingshan, Henan, China

Site Status RECRUITING

Xuchang central Hospital

Xuchang, Henan, China

Site Status RECRUITING

The Second Affiliated Hospital of Henan University of science and technology

Zhengzhou, Henan, China

Site Status RECRUITING

The Third People's Hospital of Zhengzhou

Zhengzhou, Henan, China

Site Status RECRUITING

Zhengzhou People's Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Zhoukou Central Hospital

Zhoukou, Henan, China

Site Status RECRUITING

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Haiming Zhang

Role: primary

Xuejin Liu

Role: primary

Hongwei Chen

Role: primary

Caifeng Mi

Role: primary

Guangwei Ding

Role: primary

Zhiqiang Ma

Role: primary

Yi Cui

Role: primary

Pei Chen

Role: primary

Xuejin Liu

Role: primary

Yu Huang, Master

Role: primary

Hong Lu, Ph.D

Role: backup

Other Identifiers

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rjhy20240814

Identifier Type: -

Identifier Source: org_study_id