Helicobacter Pylori Eradication Rates of Bismuth-containing Quadruple Therapy vs Modified Quadruple Therapy in Korea

NCT ID: NCT03665428

Last Updated: 2020-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 233 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-16
• Study Completion Date: 2019-12-31

Brief Summary

South Korea has the highest incidence of gastric cancer worldwide and Helicobacter pylori infection is still prevalent. Clarithromycin-containing triple therapy is still the primary therapy approved by the Korean government. However, studies of antibiotic resistance has shown that regional resistance pattern to antibiotics such as clarithromycin, metronidazole, or quinolone. Recent study in Korea has shown that modified-quadruple therapy has comparable eradication rate to concomitant therapy. However, there has been no comparable study of modified-quadruple therapy with bismuth-containing quadruple therapy. The aim of this study is to compare the eradication rate of modified-quadruple therapy and bismuth-containing quadruple therapy with presenting phenotypic and genotypic antibiotic resistance profile.

Detailed Description

South Korea has the highest incidence of gastric cancer worldwide and Helicobacter pylori infection is still prevalent. Clarithromycin-containing triple therapy is still the primary therapy approved by the Korean government. However, studies of antibiotic resistance has shown that regional resistance pattern to antibiotics such as clarithromycin, metronidazole, or quinolone. Recent study in Korea has shown that modified-quadruple therapy has comparable eradication rate to concomitant therapy. However, this study did not explore the antibiotic resistance profile of Helicobacter pylori. And, there has been no comparable study of modified-quadruple therapy with bismuth-containing quadruple therapy. The aim of this study is to compare the eradication rate of modified-quadruple therapy and bismuth-containing quadruple therapy with presenting phenotypic and genotypic antibiotic resistance profile.

Conditions

Helicobacter Pylori Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PAMB group

PAMB treatment (modified quadruple therapy) for 14 days

Group Type: EXPERIMENTAL

PAMB treatment (modified quadruple therapy)

Intervention Type: DRUG

Randomly assign either as PAMB or PBMT group treatment

PMBT group

PBMT treatment (bismuth-containing quadruple therapy) for 14 days

Group Type: ACTIVE_COMPARATOR

PBMT treatment (bismuth-containing quadruple therapy)

Intervention Type: DRUG

Randomly assign either as PAMB or PBMT group treatment

Interventions

PAMB treatment (modified quadruple therapy)

Randomly assign either as PAMB or PBMT group treatment

Intervention Type: DRUG

PBMT treatment (bismuth-containing quadruple therapy)

Randomly assign either as PAMB or PBMT group treatment

Intervention Type: DRUG

Other Intervention Names

PBMT treatment (bismuth-containing quadruple therapy); PAMB treatment (modified quadruple therapy)

Eligibility Criteria

Inclusion Criteria

• Participants who had upper endoscopic examination within 3 months and diagnosed by Helicobacter pylori infection either by rapid urease test, urea breath test, or histopathologic examination.
• Participants who voluntarily want to participate in this study.

Exclusion Criteria

• Participants who had history of Helicobacter pylori eradication.
• Participants who had experience of stomach resection.
• Participants who had history of allergy or adverse events related to eradication medication.
• Participants who had history of administration of proton-pump inhibitor within 2 weeks or Histamine 2 receptor blocker within 1 week.
• Participants who had history of administration of these drugs within a week or who need continuous administration of these drugs; aspirin (except low-dose aspirin for primary prophylaxis of cardiovascular disease), intravenous or oral NSAID, anticholinergics, prostaglandin analogs, pro-motility drugs, sucralfate
• Participants who had history of administration of antibiotics within 4 weeks.
• Pregnant, breast feeding participant or who do not have a will to avoid pregnancy during clinical trial
• Participants who are administrating one of these drugs (Lovastatin, Simvastatin, Atorvastatin, Indinavir, Ritonavir, Cyclosporin, Terfenadine, Cisapride, Pimozide, Astemizole, HIV protease inhibitors (Atazanavir, Nelfinavir), Ergotamine, Dihydroergotamine, Mizolastine, Bepridil, Ticagrelor)
• Participants who have infectious mononucleosis, central nervous system infection, hematologic disease, galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, Torsades de pointes.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hallym University Medical Center

OTHER

Sponsor Role: collaborator

Chuncheon Sacred Heart Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chang Seok Bang

Associate professor of Hallym University College of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chang Seok Bang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hallym University

Locations

Chuncheon Sacred Heart hospital

Chuncheon, Gangwon-do, South Korea

Countries

South Korea

Other Identifiers

CSBang2018HP

Identifier Type: -

Identifier Source: org_study_id