NCT03130452

Helicobacter Pylori Eradication Study

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 423 (actual)
• Sponsor: Inje University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Lansoprazole 30mg	lansoprazole 30 mg tablet
DRUG	Amoxicillin 1.0g Tab	Amoxicillin 1.0g tablet
DRUG	Clarithromycin 500mg	Clarithromycin 500mg tablet
DRUG	Metronidazole 500 mg	Metronidazole 500 mg tablet

Timeline

• Start date: 2016-12-17
• Primary completion: 2019-01-28
• Completion: 2019-05-31
• First posted: 2017-04-26
• Last updated: 2025-05-01

Locations

1 site across 1 country: South Korea