Antimicrobial Susceptibility Testing Guided Therapy Versus Empirical Therapy for the First-line Helicobacter Pylori Eradication.

Helicobacter Pylori Infection Clinical Trial

Official title:

10-Day Antimicrobial Susceptibility Testing Guided Triple Therapy Versus 14-Day Empirical Tailored Therapy for the First-line Treatment of Helicobacter Pylori Infection-A Randomized Controlled Trail

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03571230
• Other study ID #: 2017SDU-QILU-G003
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 1, 2018
• Est. completion date: January 30, 2020

Study information

• Verified date: June 2018
• Source: Shandong University
• Contact: Xiuli Zuo, PhD,MD
• Phone: 15588818685
• Email: zuoxiuli[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess efficacy of 10-day antimicrobial susceptibility test guided triple therapy for the first-line treatment of Helicobacter pylori infection, then comparing it with 14-day empirical tailored therapy to tell which one has a better performance in both efficacy and safety.

Description:

Helicobacter pylori(H.pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathologies. Antimicrobial susceptibility test can pick out sensitive drugs to kill Helicobacter pylori, and reduce secondary drug resistance. But, there is a lack of high quality RCT to compare its efficacy with empirical regimen in the first-line treatment.

Our study aims to assess the efficacy of 10-day antimicrobial susceptibility test guided triple therapy for the first-line treatment of Helicobacter pylori infection. Comparing this regimen with 14-day Empirical Tailored Therapy to tell which one is better in clinic practice. We also want to find whether the 10-day antimicrobial susceptibility test guided triple therapy has less intestinal dysbacteriosis with a shorter duration.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: January 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients aged 18-70 with H. pylori infection.

Exclusion Criteria:

• Patients with previous H. pylori eradication therapy;

• Patients unable or unwilling to receive gastroscopy;

• Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks;

• Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;

• Patients with known or suspected allergy to study medications;

• Currently pregnant or lactating;

• Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Related Conditions & MeSH terms

• Antimicrobial Susceptibility Testing
• Disease Susceptibility
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection

Intervention

Drug:
• two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline)
Patients will receive a 10-day triple therapy for the H.pylori eradication. The regimen contains one PPI and two sensitive antibiotics determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated.
• two antibiotics based on personal medication history(amoxicillin,clarithromycin,furazolidone)
Patients will receive a 14-day bismuth-based quadruple therapy for the H.pylori eradication. The regimen contains one PPI, Colloidal Bismuth Pectin and two antibiotics based on personal medication history. If the patient has taken clarithromycin, roxithromycin and azithromycin for less than 2 weeks before, he will be treated with amoxicillin and clarithromycin. Otherwise, he will be treated with amoxicillin and furazolidone.
• one proton pump inhibitor(PPI)
All the patients need this drug.
• Colloidal Bismuth Pectin
All the patients treated with 14-day bismuth-based quadruple therapy need this drug.
• two antibiotics for failed eradication(tetracyclin,furazolidone)
If the patients failed with AST guided eradication therapy or empirical therapy, patients will be treated with another 14-day bismuth-based quadruple therapy. The regimen contains one PPI, Colloidal Bismuth Pectin, tetracycline and furazolidone.

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 in 2 groups	Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. 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 improving dyspepsia symptoms after Helicobacter pylori eradication.	Dyspepsia symptoms will be measured using a 8-point Likert scale, and patients rate their symptoms from 0 (none) to 8 (severe) before and after the Helicobacter pylori eradication.	6 months
Secondary	The rate of adverse events happening	Similarly, adverse events will also be measured by the Likert scale.	6 months
Secondary	The rate of good compliance	Patients taken over 90% of drugs are considered to have a good compliance.	6 months
Secondary	Difference of cost per patient for each eradication achieved in two groups		6 months