Helicobacter Pylori Eradication Study

Inje University

Status and phase: Completed; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Clarithromycin 500mg; Drug: Metronidazole 500 mg; Drug: Lansoprazole 30mg; Drug: Amoxicillin 1.0g Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT03130452

2016-09-0025

Details and patient eligibility

About

The purpose of this study was to evaluate the efficacy and compliance of tailored therapy which using the polymerase chain reaction for point mutation of clarithromycin, compared to concomitant therapy, in patients without history of H. pylori eradication.

Full description

Purpose of Study>

1. To evaluate the efficacy of tailored therapy compared to concomitant therapy.
2. Difference in eradication rate according to the frequency of 23S ribosomal RNA point mutation in clarithromycin.
3. To evaluate the compliance of tailored therapy compared to concomitant.
4. To analysis of factors which influence to the eradication rate.

Patients>

; Target disease

• peptic ulcers(gastric ulcer, duodenal ulcer),
• gastric MALToma,
• Endoscopic therapy state of early gastric cancer or gastric adenoma,
• Patients who require H. pylori testing by clinical judgment, such as chronic gastritis.

Method>

Patients with H. pylori infection who have been screened for a 23S ribosomal RNA point mutation (A2142G, A2143G point mutation) and randomized to a concomitant treatment group and a tailored treatment group. In concomitant treatment group, lansoprazole 30 mg, amoxicillin 1.0 g, metronidazole 500 mg and clarithromycin 500 mg were administered twice a day for 2 weeks, regardless of 23S ribosomal RNA point mutation. In tailored treatment group, In the case of 23S ribosomal RNA point mutation negative, lansoprazole 30 mg, amoxicillin 1.0 g, and clarithromycin 500 mg were administered twice a day for 2 weeks. In tailored treatment group, In point mutation positive cases, lansoprazole 30 mg, amoxicillin 1.0 g and metronidazole 500 mg For 2 weeks. For each treatment group, at least 4 weeks after completion of drug administration, confirm the sterilization and confirm the compliance and adverse effects of the drug.

Enrollment: 423 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• H. pylori infection diagnosed patient, between 18 years old and 80 years old
• No history of H. pylori eradication therapy
• No antibiotic use for more than 3 days within 1 month of treatment

Exclusion criteria

• History of taking antibiotics for more than 3 days in the last 1 month
• History of subtotal or partial gastrectomy
• Patients with other systemic disorders such as severe liver function, kidney function, cardiopulmonary function abnormality
• Pregnant and lactating women
• Disagree with the survey or do not respond to the questionnaire
• Contraindications for each medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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423 participants in 3 patient groups

concomitant group

Active Comparator group

Description:

lansoprazole 30 mg tablet, amoxicillin 1.0 g tablet, metronidazole 500 mg tablet and clarithromycin 500 mg tablet by mouth every 12 hours for 2 weeks, regardless of 23S ribosomal RNA point mutation.

Treatment:

Drug: Amoxicillin 1.0g Tab

Drug: Lansoprazole 30mg

Drug: Metronidazole 500 mg

Drug: Clarithromycin 500mg

tailored treatment group I

Experimental group

Description:

23S ribosomal RNA point mutation negative, lansoprazole 30 mg, amoxicillin 1.0 g, and clarithromycin 500 mg were administered twice a day for 2 weeks.

Treatment:

Drug: Amoxicillin 1.0g Tab

Drug: Lansoprazole 30mg

Drug: Clarithromycin 500mg

tailored treatment group II

Experimental group

Description:

23S ribosomal RNA point mutation positive, lansoprazole 30 mg, amoxicillin 1.0 g and metronidazole 500 mg For 2 weeks.

Treatment:

Drug: Lansoprazole 30mg

Drug: Metronidazole 500 mg

Drug: Clarithromycin 500mg