Helicobacter Pylori Eradication Study

Helicobacter Pylori Infection Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03130452
• Other study ID #: 2016-09-0025
• Status: Active, not recruiting
• Phase: Phase 4
• First received: April 5, 2017
• Last updated: April 21, 2017
• Start date: February 1, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: April 2017
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 280
• Est. completion date: May 31, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

Drug:
• Lansoprazole 30mg
lansoprazole 30 mg tablet
• Amoxicillin 1.0g Tab
Amoxicillin 1.0g tablet
• Clarithromycin 500mg
Clarithromycin 500mg tablet
• Metronidazole 500 mg
Metronidazole 500 mg tablet

Locations

Country	Name	City	State
Korea, Republic of	Inje University Busan Paik hosipital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of remaining medicines of tailored therapy compared to concomitant therapy	After taking the treatment drug, take out all remaining medicine in the outpatient clinic room, check the number of remaining medicines, and judge compliance.	At 4 weeks after the completion of drug administration, when the patient visited for the urea breath test, check the number of remaining medicines.
Primary	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)	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	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.	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.