Helicobacter Pylori Eradication Study

NCT ID: NCT03130452

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 423 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-17
• Study Completion Date: 2019-05-31

Brief Summary

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.

Detailed 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.

Conditions

Helicobacter Pylori Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

concomitant group

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.

Group Type: ACTIVE_COMPARATOR

Lansoprazole 30mg

Intervention Type: DRUG

lansoprazole 30 mg tablet

Amoxicillin 1.0g Tab

Intervention Type: DRUG

Amoxicillin 1.0g tablet

Clarithromycin 500mg

Intervention Type: DRUG

Clarithromycin 500mg tablet

Metronidazole 500 mg

Intervention Type: DRUG

Metronidazole 500 mg tablet

tailored treatment group I

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.

Group Type: EXPERIMENTAL

Lansoprazole 30mg

Intervention Type: DRUG

lansoprazole 30 mg tablet

Amoxicillin 1.0g Tab

Intervention Type: DRUG

Amoxicillin 1.0g tablet

Clarithromycin 500mg

Intervention Type: DRUG

Clarithromycin 500mg tablet

tailored treatment group II

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

Group Type: EXPERIMENTAL

Lansoprazole 30mg

Intervention Type: DRUG

lansoprazole 30 mg tablet

Clarithromycin 500mg

Intervention Type: DRUG

Clarithromycin 500mg tablet

Metronidazole 500 mg

Intervention Type: DRUG

Metronidazole 500 mg tablet

Interventions

Lansoprazole 30mg

lansoprazole 30 mg tablet

Intervention Type: DRUG

Amoxicillin 1.0g Tab

Amoxicillin 1.0g tablet

Intervention Type: DRUG

Clarithromycin 500mg

Clarithromycin 500mg tablet

Intervention Type: DRUG

Metronidazole 500 mg

Metronidazole 500 mg tablet

Intervention Type: DRUG

Other Intervention Names

langton; amoxiclav; clavacin; lysinyl

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inje University

OTHER

Sponsor Role: lead

Responsible Party

Kim Ji Hyun

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ji Hyun Kim

Role: PRINCIPAL_INVESTIGATOR

Inje University Busan Paik hosipital

Locations

Inje University Busan Paik hosipital

Busan, , South Korea

Countries

South Korea

Other Identifiers

2016-09-0025

Identifier Type: -

Identifier Source: org_study_id