Antimicrobial Susceptibility Testing Guided Triple Therapy in Salvage Helicobacter Pylori Treatment

Sponsor

Yanqing Li (Other)

Overall Status

Unknown status

CT.gov ID

NCT03139253

Collaborator

(none)

120

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Antimicrobial Susceptibility Testing Triple Therapy	Drug: amoxicillin Drug: clarithromycin Drug: tinidazole Drug: levofloxacin Drug: furazolidone Drug: tetracycline Drug: Ilaprazole	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Antimicrobial Susceptibility Testing Guided Triple Therapy in Salvage Helicobacter Pylori Treatment

Anticipated Study Start Date :

May 30, 2017

Anticipated Primary Completion Date :

Jun 30, 2017

Anticipated Study Completion Date :

Jun 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: clarithromycin susceptible Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and clarithromycin. Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI).	Drug: amoxicillin amoxicillin 1000 mg bid. for 14 days Drug: clarithromycin clarithromycin 500 mg bid. for 14 days. Drug: Ilaprazole Ilaprazole 5 mg bid. for 14 days.
Experimental: metronidazole susceptible Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tinidazole.	Drug: amoxicillin amoxicillin 1000 mg bid. for 14 days Drug: tinidazole tinidazole 500 mg bid. for 14 days. Drug: Ilaprazole Ilaprazole 5 mg bid. for 14 days.
Experimental: levofloxacin susceptible Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and levofloxacin.	Drug: amoxicillin amoxicillin 1000 mg bid. for 14 days Drug: levofloxacin levofloxacin 500 mg qd. for 14 days. Drug: Ilaprazole Ilaprazole 5 mg bid. for 14 days.
Experimental: furazolidone susceptible Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and furazolidone.	Drug: amoxicillin amoxicillin 1000 mg bid. for 14 days Drug: furazolidone furazolidone 100 mg bid. for 14 days. Drug: Ilaprazole Ilaprazole 5 mg bid. for 14 days.
Experimental: tetracycline susceptible Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tetracycline.	Drug: amoxicillin amoxicillin 1000 mg bid. for 14 days Drug: tetracycline tetracycline 750 mg bid. for 14 days. Drug: Ilaprazole Ilaprazole 5 mg bid. for 14 days.

Outcome Measures

Primary Outcome Measures

Eradication rate of AST guided triple therapy [3 months]

Secondary Outcome Measures

the rate of improving dyspepsia symptoms after H. pylori eradication [3 months]
the rate of adverse events happening [3 months]
the rate of good compliance (take pills more than 90%) [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Consecutive patients who are 18-70 years old with persistent H. pylori infection after first or second line treatment attempts.

Exclusion Criteria:

Enable to undergo upper endoscopy;
Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
Known or suspected allergy to study medications;
Taking bismuth and antibiotics in the previous four weeks, or taking proton pump inhibitor and H2-receptor blockers in the previous two weeks;
Currently pregnant or lactating
Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.