Clinical trial NCT03130452: Helicobacter Pylori Eradication Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 423
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of success rate of H. pylori eradication between tailored therapy and concomitant therapy.
timeFrame: 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:
measure: Difference in eradication rate according to the frequency of 23S ribosomal RNA point mutation in clarithromycin
timeFrame: 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:
measure: Number of remaining medicines of tailored therapy compared to concomitant therapy
timeFrame: At 4 weeks after the completion of drug administration, when the patient visited for the urea breath test, check the number of remaining medicines.
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik hosipital
Study officials:
affiliation: Inje University Busan Paik hosipital
name: Ji Hyun Kim
role: PRINCIPAL_INVESTIGATOR
References: