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Completed

NCT Number: NCT03130452

Helicobacter Pylori Eradication Study

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.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Inje University Busan Paik hosipital

Busan, South Korea

About this study

Purpose of Study>

  • To evaluate the efficacy of tailored therapy compared to concomitant therapy.
  • Difference in eradication rate according to the frequency of 23S ribosomal RNA point mutation in clarithromycin.
  • To evaluate the compliance of tailored therapy compared to concomitant.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lansoprazole 30mg

Drug

lansoprazole 30 mg tablet

Other names: langton

Amoxicillin 1.0g Tab

Drug

Amoxicillin 1.0g tablet

Other names: amoxiclav

Clarithromycin 500mg

Drug

Clarithromycin 500mg tablet

Other names: clavacin

Metronidazole 500 mg

Drug

Metronidazole 500 mg tablet

Other names: lysinyl

Primary outcomes

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

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

Secondary outcomes

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

    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.

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

Other outcomes

  1. Number of remaining medicines of tailored therapy compared to concomitant therapy

    Time frame: At 4 weeks after the completion of drug administration, when the patient visited for the urea breath test, check the number of remaining medicines.

    After taking the treatment drug, take out all remaining medicine in the outpatient clinic room, check the number of remaining medicines, and judge compliance.

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Official study title

Helicobacter Pylori Eradication Rates of Concomitant Therapy and Tailored Therapy Based on 23S Ribosomal RNA Point Mutations Associated With Clarithromycin Resistance: A Multicenter Prospective Randomized Study

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 26, 2017
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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