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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03665428
• Other study ID #: CSBang2018HP
• Status: Completed
• Phase: Phase 4
• Start date: July 16, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2020
• Source: Chuncheon Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: December 31, 2019
• Est. primary completion date: August 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection

Intervention

Drug:
• PAMB treatment (modified quadruple therapy)
Randomly assign either as PAMB or PBMT group treatment
• PBMT treatment (bismuth-containing quadruple therapy)
Randomly assign either as PAMB or PBMT group treatment

Locations

Country	Name	City	State
Korea, Republic of	Chuncheon Sacred Heart hospital	Chuncheon	Gangwon-do

Sponsors (2)

Lead Sponsor	Collaborator
Chuncheon Sacred Heart Hospital	Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of adverse events related to eradication medication	Adverse events related to eradication medication	up to 4 weeks
Secondary	Rate of compliance of eradication medication administration	Compliance (percentage of amount) of eradication medication administration	up to 4 weeks