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Report for Clinical Trial NCT03130452

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT03130452 Helicobacter Pylori Infection

4 Interventions

Name: Lansoprazole 30mg

Description: lansoprazole 30 mg tablet

Type: Drug

concomitant group tailored treatment group I tailored treatment group II

Name: Amoxicillin 1.0g Tab

Description: Amoxicillin 1.0g tablet

Type: Drug

concomitant group tailored treatment group I

Name: Clarithromycin 500mg

Description: Clarithromycin 500mg tablet

Type: Drug

concomitant group tailored treatment group I tailored treatment group II

Name: Metronidazole 500 mg

Description: Metronidazole 500 mg tablet

Type: Drug

concomitant group tailored treatment group II


Primary Outcomes

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

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

Time: 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

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

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

Time: 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.

Other Outcomes

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

Measure: Number of remaining medicines of tailored therapy compared to concomitant therapy

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

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 A2142G

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. --- A2142G ---


2 A2143G

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. --- A2142G --- --- A2143G ---



HPO Nodes