Efficacy and Safety of 14-day Concomitant Therapy for Refractory Helicobacter Pylori Infection

NCT ID: NCT05133193

Last Updated: 2021-11-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-20
• Study Completion Date: 2022-06-30

Brief Summary

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

Detailed Description

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.

Few published paper evaluated the efficacy of 14-day furazolidone containing concomitant therapy in the third line treatment. 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

Helicobacter Pylori Infection

Keywords

Concomitant Therapy,Rescue treatment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

14d concomitant therapy

The eligible patients received 14-day concomitant therapy, including vonoprazan and three kinds of antibiotics according to the previous eradication regimens and antibiotic use. Antibiotics are selected from Amoxicillin, Tetracycline, Furazolidone, Levofloxacin, Clarithromycin, Tinidazole, Metronidazole.

Group Type: EXPERIMENTAL

three kinds of antibiotics

Intervention Type: DRUG

All patients were educated carefully about the medical instructions, including the duration of treatment, possible side effect, the necessity of completing the full 14-day course.

Interventions

three kinds of antibiotics

All patients were educated carefully about the medical instructions, including the duration of treatment, possible side effect, the necessity of completing the full 14-day course.

Intervention Type: DRUG

Other Intervention Names

antibiotics

Eligibility Criteria

Inclusion Criteria

• Patients aged 18-70 years were recruited for this study if they had failed at least three rounds of anti- H. pylori therapies.

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,
• 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

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Xiuli Zuo

Director of Qilu Hospital gastroenterology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2020-SDU-QILU-G057

Identifier Type: -

Identifier Source: org_study_id