Prospective Study : Helicobacter Pylori Eradication Therapy in Accordance With Past Antibiotics Use

Ajou University School of Medicine

Status and phase: Unknown; Phase 4

Conditions: Helicobacter Eradication

Treatments: Drug: Helicobacter pylori eradication

Study type: Interventional

Funder types: Other

Identifiers

NCT01938534

AJOU-EIRB-152692

Details and patient eligibility

About

Prospective study : Helicobacter pylori eradication therapy in accordance with past antibiotics use.

Full description

Antibiotics resistant is serious problem in helicobacter pylori eradication. Clarithromycin is very important antibiotics in eradication. But clarithromycin resistance is increased. Major cause of clarithromycin resistance is past consumption of macrolide. Thus the investigators propose eradication of macrolide used group bismuth contained four drugs therapy.

Enrollment: 440 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Peptic ulcer disease
• Gastric MALT lymphoma
• Early gastric cancer
• Familial history of gastric cancer
• Idiopathic iron deficiency
• Chronic idiopathic thrombocytopenia
• Atrophic gastritis
• Helicobacter infected dyspepsia
• Long term NSAIDs use

Exclusion criteria

• Pregnant
• Previous proton pump inhibitor, antibiotics or anticoagulant use within 2 weeks
• Previous stomach surgery
• Severe ill patients (heart failure, hepatic failure, renal failure, hematologic disorder, severe psychologic or neurologic disorder)
• Previous Helicobacter eradication
• Allergy for Helicobacter eradication medicine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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440 participants in 2 patient groups

Experimental

Experimental group

Description:

Omeprazole 30mg twice Clarithromycin 500mg twice Amoxicillin 1000mg twice for 10 days

Treatment:

Drug: Helicobacter pylori eradication

Control

Active Comparator group

Description:

Tetracycline 500mg four times Omeprazole 30mg twice Bismuth 600mg twice Metronidazole 500mg three times for 10 days

Treatment:

Drug: Helicobacter pylori eradication