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

Helicobacter Pylori Eradication Rates of Bismuth-containing Quadruple Therapy vs Modified Quadruple Therapy in Korea; Open-label, Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: PAMB treatment (modified quadruple therapy); Drug: PBMT treatment (bismuth-containing quadruple therapy)

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.

• Study Type: Interventional
• Enrollment (Actual): 233
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangwon-do
    • Chuncheon, Gangwon-do, Korea, Republic of, 24253
      • Chuncheon Sacred Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PAMB group; PAMB treatment (modified quadruple therapy) for 14 days	Drug: PAMB treatment (modified quadruple therapy); Randomly assign either as PAMB or PBMT group treatment; Other Names: PBMT treatment (bismuth-containing quadruple therapy)
ACTIVE_COMPARATOR: PMBT group; PBMT treatment (bismuth-containing quadruple therapy) for 14 days	Drug: PBMT treatment (bismuth-containing quadruple therapy); Randomly assign either as PAMB or PBMT group treatment; Other Names: PAMB treatment (modified quadruple therapy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of eradication success	Eradication success means negative urea breath test done at least after 4 weeks from medication administration	up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of adverse events related to eradication medication	Adverse events related to eradication medication	up to 4 weeks
Rate of compliance of eradication medication administration	Compliance (percentage of amount) of eradication medication administration	up to 4 weeks

Collaborators and Investigators

• Sponsor: Chuncheon Sacred Heart Hospital
• Collaborators: Hallym University Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 16, 2018
• Primary Completion (ACTUAL): August 6, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: June 25, 2018
• First Submitted That Met QC Criteria: September 8, 2018
• First Posted (ACTUAL): September 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 21, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Drug Resistance, Microbial; helicobacter pylori infection
• Additional Relevant MeSH Terms: Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Helicobacter Infections; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Antacids; Bismuth
• Other Study ID Numbers: CSBang2018HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No