A Pilot Study of a 14-day Modified Sequential Therapy for Helicobacter Pylori Infection

Helicobacter Pylori Infection Clinical Trial

Official title:

Efficacy and Safety of a 14-day Modified Sequential Therapy for Refractory Helicobacter Pylori Infection: an Open Randomized Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03658733
• Other study ID #: 2018SDU-QILU-G002
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 15, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: December 2018
• Source: Shandong University
• Contact: Xiuli Zuo, PhD,MD
• Phone: 8653182169025
• Email: qlywc[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess efficacy of a new 14-day sequential therapy for the rescue treatment of refractory Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates. The researchers also want to testify whether a double-dose rabeprazole has equal efficacy to double-dose esomeprazole to provide sufficient acid inhibition.

Description:

Half of the world's population is infected with Helicobacter pylori. Strong evidence supports that 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 emerging antibiotic resistance of H. pylori worldwide. An ideal rescue therapeutic regimen to cure refractory H.pylori infection is currently warranted. Traditional sequential therapy failed to achieve an ideal eradication rates (over>95%) as a third line treatment in the region with high antibiotic resistance. This study aims to evaluate the efficacy of 14-day modified sequential therapy in the patients with two or more treatment failure, and whether the adverse effects of this new modified sequential therapy are tolerable. Then, this study will also compare the performance of a double-dose esomeprazole with double-dose rabeprazole containing therapy to optimize therapeutic regimen.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: October 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 unable or unwilling to receive gastroscopy.

• Patients treated with H2-receptor antagonist, PPI, 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• esomeprazole, amoxicillin, tetracycline, furazolidone (only for the first 7 days), colloidal bismuth pectin (for the second 7 days)
Patients will go through a gastroscopy and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment. Then, patients will receive a 14-day modified sequential therapy containing esomeprazole for the Helicobacter pylori eradication. The regimen contains a double dose esomeprazole, amoxicillin, tetracycline and furazolidone for the first 7 days, followed by esomeprazole, amoxicillin , tetracycline and colloidal bismuth pectin for the second 7 days.
• rabeprazole, amoxicillin, tetracycline, furazolidone (only for the first 7 days), colloidal bismuth pectin (for the second 7 days)
Patients will go through a gastroscopy and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment. Then, patients will receive a 14-day modified sequential therapy containing rabeprazole for the Helicobacter pylori eradication. The regimen contains a double-dose rabeprazole, amoxicillin, tetracycline and furazolidone for the first 7 days, followed by rabeprazole, amoxicillin , tetracycline and colloidal bismuth pectin for the second 7 days.

Locations

Country	Name	City	State
China	Xiuli Zuo	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication rates	Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infection. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.	6 months
Secondary	The rate of adverse events happening	Parameters of liver and kidney function before and after the treatment will be compared. Common adverse events will be measured and patients will rate the severity of their symptoms from 0 (none) to 8 (severe) points during the treatment process.	6 months
Secondary	The change of dyspepsia symptoms after Helicobacter pylori eradication	Dyspepsia symptoms will be recorded before and after the treatment. Patients will rate the severity of their symptoms from 0 (none) to 8 (severe) points.	6 months
Secondary	The rate of good compliance	Patients taken over 90% of drugs are considered to have a good compliance.	6 months