Clinical trial NCT04006340: Empirical vs Tailored Therapy for H. Pylori Infection
Official title: Comparison of Empirical and Genotypic Resistance Guided Tailored Therapy for Helicobacter Pylori Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation
Helicobacter Pylori Infection
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We aimed to compare the efficacy of genotypic resistance-guided tailored therapy vs empirical therapy for eradication of Helicobacter pylori (H. pylori) infection in randomized controlled trials.

Detailed description: Empirical therapy is conventional triple therapy (proton pump inhibitor (PPI) standard dose, amoxicillin 1 g and clarithromycin 500 mg twice a day for 10 days). Genotypic resistance-guided tailored therapy is the method which is chosen by DPO-PCR test. While the patients who have positive result of clarithromycin resistance receive the quadruple therapy(PPI standard dose, bismuth 300mg twice daily, tetracycline 500 mg four times daily, metronidazole 500mg three times daily for 10 days), clarithromycin susceptible patients receive the triple therapy.

H. pylori is difficult to cultivate, cultivation of H. pylori and minimum inhibitory concentration test as a resistance test method are very difficult and take a long time. Recently, tailored treatment based on clarithromycin susceptibility has been proposed by dual-priming oligonucleotide-based multiplex (DPO)-PCR test. This is a method to confirm the mutation of A2142G and A2143G by PCR, which are known to be highly related to the resistance of clarithromycin 23S rRNA point mutation. This test is performed only by gastric biopsy. The examination time is also short as several hours, and sensitivity and specificity are about 80-85%.

Antibiotic resistance of H. pylori, especially clarithromycin resistance, is a cause of major failure of its eradication, and Korea 's clarithromycin resistance rate is reported to be about 37%. The eradication rate of standard triple therapy reported in Korea is also unsatisfactory as antibiotic resistance rate of H. pylori increases. The ideal eradication rate for H. pylori is approximately 90%, but in the meta-analysis of the recently reported primary eradication, the overall eradication rate was 74.6% in the intention to treat analysis.

Eligibility criteria: Inclusion Criteria:

* Patients with H. pylori who had undergone endoscopic resection for gastric neoplasm
* Patients with H. pylori who had diagnosed at peptic ulcer disease, MALT lymphoma

Exclusion Criteria:

* history of gastrectomy
* patients aged younger than 20 years or older than 80 years
* history of H. pylori eradication therapies or other antibiotics therapy within a month
* previous allergic reaction to the study drugs (amoxicillin, clarithromycin, metronidazole, tetracycline, and esomeprazole)
* contraindication to treatment drugs
* pregnant or lactating women
* severe concurrent illness

Primary outcomes:
measure: Eradication rate
timeFrame: 13C-UBT at least 4 weeks after completion of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Department of Internal Medicine and Liver Research Institute,
name: Soo-Jeong Cho, M.D., ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim JL, Cho SJ, Chung SJ, Lee A, Choi J, Chung H, Kim SG. Empiric Versus Clarithromycin Resistance-Guided Therapy for Helicobacter pylori Based on Polymerase Chain Reaction Results in Patients With Gastric Neoplasms or Gastric Mucosa-Associated Lymphoid Tissue Lymphoma: A Randomized Controlled Trial. Clin Transl Gastroenterol. 2020 Sep;11(9):e00194. doi: 10.14309/ctg.0000000000000194.