Clinical trial NCT03571230: Antimicrobial Susceptibility Testing Guided Therapy Versus Empirical Therapy for the First-line Helicobacter Pylori Eradication.
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Antimicrobial Susceptibility Testing
Keywords: Helicobacter Pylori Infection
Antimicrobial Susceptibility testing(AST)
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Eradication rates in 2 groups
timeFrame: 6 months
Secondary outcomes:
measure: The rate of improving dyspepsia symptoms after Helicobacter pylori eradication.
timeFrame: 6 months
measure: The rate of adverse events happening
timeFrame: 6 months
measure: The rate of good compliance
timeFrame: 6 months
measure: Difference of cost per patient for each eradication achieved in two groups
timeFrame: 6 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Xiuli Zuo
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References: