Clinical trial NCT02159976: Compare Sequential and Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea
Official title: A Prospective, Multi-center, Randomized, Open-label, Parallel Design Clinical Trial to Compare 10-day Sequential Therapy and 14-day Modified Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: SK Chemicals Co., Ltd.
name: Chong Kun Dang Pharmaceutical
name: HK inno.N Corporation
name: Green Cross Corporation
First posted: 2014-06-10
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. To compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and to establish more effective first-line regimen for the eradication of Helicobacter pylori in Korea.
2. To evaluate the effect of H. pylori eradication therapy on the symptom improvement of functional dyspepsia

Detailed description: Emerging evidence shows that the eradication rate of proton pump inhibitor (PPI)-based triple therapy for the first-line treatment of Helicobacter pylori has decreased. The reason for the decrease in the efficacy of PPI-based triple therapy is mainly due to the increase in the resistance against clarithromycin. Sequential therapy seems to be more effective than the PPI-based triple therapy, however, the eradication rate of sequential therapy in Korea, which is mostly under 80%, is still not satisfactory. Modified bismuth quadruple therapy which replace metronidazole with amoxicillin (contained PPI, bismuth, tetracycline and amoxicillin) can be a promising regimen because the antibiotic resistance rate of tetracycline and amoxicillin are relatively low in Korea and amoxicillin is more easy to take in comparing with metronidazole. Therefore, the aim of this study is to compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and to establish more effective first-line regimen for the eradication of Helicobacter pylori in Korea.

In addition, previous studies reported that H. pylori infection also associated with functional dyspepsia (FD) and recommended H. pylori eradication in patients with FD. However, until now, there was no randomized prospective study in Korea, therefore the another aim of this study is to evaluate the effect of H. pylori eradication therapy on the symptom improvement of FD.

Eligibility criteria: Inclusion Criteria:

* Male and female Korean Adult (Aged ≥ 18 years)
* Patients who diagnosis of H. pylori infection by any of following three methods

  * positive rapid urease test (CLOtest)
  * histologic evidence of H. pylori by modified Giemsa staining
  * positive 13C-urea breath test

Exclusion Criteria:

* Age under 18 years
* Previous eradication treatment for H. pylori
* Patients who took any drug which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics
* History of gastrectomy
* 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: Counts of Participants With Successful H. Pylori Eradication
timeFrame: 4 weeks after termination of eradication therapy, up to 6 weeks
Secondary outcomes:
measure: Counts of Participants Whose Drug Compliance is More Than 85%
timeFrame: 4 weeks after termination of eradication therapy, up to 6 weeks
measure: Counts of Participants With Adverse Event
timeFrame: 4 weeks after termination of eradication therapy, up to 6 weeks
measure: Functional Dyspepsia Symptom Responses Rate
timeFrame: 1 year after termination of eradication therapy
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
citation: Lee JY, Kim N, Park KS, Kim HJ, Park SM, Baik GH, Shim KN, Oh JH, Choi SC, Kim SE, Kim WH, Park SY, Kim GH, Lee BE, Jo Y, Hong SJ. Comparison of sequential therapy and amoxicillin/tetracycline containing bismuth quadruple therapy for the first-line eradication of Helicobacter pylori: a prospective, multi-center, randomized clinical trial. BMC Gastroenterol. 2016 Jul 26;16(1):79. doi: 10.1186/s12876-016-0490-8.