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

Helicobacter Pylori Infection Clinical Trial

Official title:

Efficacy and Safety of 14-day Concomitant Therapy for Refractory Helicobacter Pylori Infection：A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05133193
• Other study ID #: 2020-SDU-QILU-G057
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 20, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2021
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication rate	Six weeks after completion of treatment,number of patients get H.pylori eradicated will be investigated.Then eradication rate will be calculated by using intention-to-treat analysis and per-protocol analysis	6 month
Secondary	The rates of adverse events	At the follow-up,adverse events complained by patients will be recorded by an inde pendent researcher, meanwhile a 8point visual analog scale (VAS) was used to evaluate severity of adverse events.	6 month
Secondary	Compliance	Compliance was evaluated by assessing the total pills patients have taken.Compliance was defined as good when more than 80% or less than 120% of the total pills were taken.	6 month