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Efficacy and Safety of 14-day Concomitant Therapy for Difficult-to-Treat Helicobacter Pylori Infection

NCT ID: NCT05126121

Last Updated: 2021-12-01

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-20

Study Completion Date

2022-12-30

Brief Summary

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The purpose of this study is to evaluate efficacy of a 14-day concomitant therapy for the treatment of Hard-to-treat Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates

Detailed Description

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Helicobacter pylori infects half of the world's population. H.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. However, eradication rates of first-line therapy decreased over years due to the rapidly increasing antibiotic resistance of H. pylori worldwide. An ideal rescue therapeutic regimen to cure refractory H.pylori infection is currently warranted.

This study aims to propose a new concomitant therapy for the patients with three or more treatment failure, and then evaluates whether adverse effects are tolerable.

Conditions

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Helicobacter Pylori Infection

Keywords

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Concomitant Therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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14d concomitant therapy

Patients will receive a 14-day concomitant therapy consisting of vonoprazan and three kinds of antibiotics including amoxicillin，tetracycline, furazolidone, clarithromycin,levofloxacin,tinidazole,metronidazole.

Group Type EXPERIMENTAL

three kinds of antibiotics including amoxicillin，tetracycline, furazolidone, levofloxacin,clarithromycin,levofloxacin,tinidazole,metronidazol

Intervention Type DRUG

Three kinds of antibiotics including amoxicillin，tetracycline, furazolidone, levofloxacin,clarithromycin,tinidazole,metronidazol

Interventions

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three kinds of antibiotics including amoxicillin，tetracycline, furazolidone, levofloxacin,clarithromycin,levofloxacin,tinidazole,metronidazol

Three kinds of antibiotics including amoxicillin，tetracycline, furazolidone, levofloxacin,clarithromycin,tinidazole,metronidazol

Intervention Type DRUG

Other Intervention Names

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antibiotics

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18-70 with persistent H. pylori infection.
* Patients failed at least three different standard eradication therapies before.Previous standard eradication therapy was defined as a 10-day or 14-day quadruple regimen designed according to Maastricht V report.

Exclusion Criteria

* Patients treated with H2-receptor antagonist, PPI, vonoprazan,bismuth and antibiotics in the previous 4 weeks.
* Patients with gastorectomy, acute GI bleeding and advanced gastric cancer.
* History of allergy to any of the drugs used in the study.
* Severe concomitant cardiovascular, respiratory, or endocrine diseases,clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk.
* Currently pregnant or lactating.
* Severe neurologic or psychiatric disorders.
* Alcohol abuse or drug addiction.
* Patients with compliance lower than 90% in any previous treatment are not included.
* Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiuli Zuo

OTHER

Sponsor Role lead

Responsible Party

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Xiuli Zuo

Director of Qilu Hospital gastroenterology department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xiuli Zuo, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Study Principal investigator

Locations

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Qilu hosipital

Jinan, Shandong, China

Site Status

Countries

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China

Central Contacts

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Xiuli Zuo, MD,PhD

Role: CONTACT

Phone: 15588818685

Email: [email protected]

Xiuli Zuo, MD,PhD

Role: CONTACT

Other Identifiers

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2021-SDU-QILU-G010

Identifier Type: -

Identifier Source: org_study_id