Helicobacter Pylori Eradication Study

Inje University423 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

423

Conditions

Helicobacter Pylori Infection

Interventions

Lansoprazole 30mgDRUG

lansoprazole 30 mg tablet

Amoxicillin 1.0g TabDRUG

Amoxicillin 1.0g tablet

Clarithromycin 500mgDRUG

Clarithromycin 500mg tablet

Metronidazole 500 mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Inje University Busan Paik hosipital

Busan, South Korea

Outcomes

Primary Outcomes

Comparison of success rate of H. pylori eradication between tailored therapy and concomitant therapy.

Comparison of percentage of people who succeeded in H. pylori eradication among all participants in each treatment group (tailored therapy vs concomitant therapy)

Time frame: At 4 weeks after the completion of drug administration, the urea breath test is performed to check for eradication, Before the urea breath test, the proton pump inhibitor or H2 blocker should be discontinued for 2 weeks.

Secondary Outcomes

Difference in eradication rate according to the frequency of 23S ribosomal RNA point mutation in clarithromycin

Identify the effect of 23S ribosomal RNA point mutation on the eradication rate regardless of the administration drug.

Time frame: Before the treatment, 23S ribosomal RNA point mutation is confirmed and at least 4 weeks after the end of treatment, urea breath test is performed to check whether or not eradication is completed.

Data from ClinicalTrials.gov

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