Clinical trial NCT02349685: The Efficacy of the Tailored Therapy Based on Antimicrobial Susceptibility for 2nd Eradication of H. Pylori
Official title: The Efficacy of the Culture Based Tailored Therapy for Helicobacter Pylori Eradication Comparing With the Traditional 2nd Line Rescue Therapy in Korean
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Helicobacter Infection
Keywords: Helicobacter pylori
Personalized therapy
antimicrobial susceptibility
rescue therapy
culture
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2015-01-29
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: As increasing the antibiotics resistance, the effectiveness of traditional Helicobacter pylori (H. pylori) therapies has been declined coincidently. In this study, the investigators evaluated the efficacy of H. pylori eradication between a personalized therapy for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the traditional 2nd rescue regimens, and the investigators analyzed the prevalence of the antibiotic resistance after 1st eradication of H. pylori in the tailored therapy group.

Detailed description: The patients who had shown the evidence of persistent H. pylori infection after the 1st eradication were enrolled for this study. After giving the informed consent about the method and efficacy (ITT and PP analysis) of the traditional 2nd rescue therapy and the tailored therapy for H. pylori infection based on culture and MIC, the patients were classified into the three regimen group under the patient's agreement and underwent 2nd eradication \[14 days bismuth-based quadruple therapy (Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d.), 14 days moxifloxacin-containing triple therapy (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.), or tailored therapy based on H. pylori culture and MIC (select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility)\].This study was analyzed the success of eradication for enrolled participants retrospectively, however the patients were enrolled prospectively based on previous study about antimicrobial susceptibility test for H. pylori in Korea.

Eligibility criteria: Inclusion Criteria:

* The patients who proved a failure of 1st eradication of H. pylori with Proton pump inhibitor based triple therapy (PPI bid + amoxacillin 1g b.i.d + Clarithromycin 500 mg b.i.d) or sequential therapy (initial 5-day therapy with a combination of PPI b.i.d and amoxicillin 1g b.i.d, followed by 5 days of PPI b.i.d., clarithromycin 500mg b.i.d., and metronidazole 500mg t.i.d) following three methods

  1. positive rapid urease test (CLOtest)
  2. histologic evidence of H. pylori by modified Giemsa staining
  3. positive 13C-Urea breath test
* Male and female Korean Adult (Aged ≥ 18 years)

Exclusion Criteria:

* Patients who received two or more eradication therapy for H. pylori infection
* H. pylori eradication failure because of poor compliance
* the administration of antibiotics or the consumption of bismuth salts within 4 weeks or the administration of a proton pump inhibitor (PPI) within 2 weeks
* Advanced gastric cancer or other malignancy
* Abnormal liver function or liver cirrhosis
* Abnormal renal function or chronic kidney disease
* Other severe concurrent diseases
* Previous allergic reactions to the study drugs
* Pregnant or lactating women

Primary outcomes:
measure: Number of Participants in Each Arm/Group With Successful H. Pylori Eradication
timeFrame: 6 weeks after completion of eradication
Secondary outcomes:
measure: Number of Participants in Each Arm/Group With Successful H. Pylori Eradication
timeFrame: 6 weeks after completion of eradication
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Nayoung Kim, M.D., Ph. D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kwon YH, Kim N, Lee JY, Choi YJ, Yoon K, Nam RH, Suh JH, Lee JW, Lee DH. Comparison of the efficacy of culture-based tailored therapy for Helicobacter pylori eradication with that of the traditional second-line rescue therapy in Korean patients: a prospective single tertiary center study. Scand J Gastroenterol. 2016 Mar;51(3):270-6. doi: 10.3109/00365521.2015.1095352. Epub 2015 Oct 9.