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Comparison of 7-day PPI-based Standard Triple Therapy and 10-day Bismuth Quadruple Therapy for H. Pylori Eradication

Primary Purpose

Helicobacter Pylori Infection, Family History of Stomach Cancer

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Standard triple therapy
Bismuth quadruple therapy
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring PPI standard triple therapy, Bismuth quadruple therapy, Helicobacter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Men and women aged 18 or more including following conditions

    • Family history of gastric cancer
    • Post endoscopic resection status for early gastric cancer or adenoma
    • Peptic ulcer disease (benign gastric ulcer and duodenal ulcer)
    • Chronic gastritis
    • Non-ulcer dyspepsia
    • Healthy adults who want to receive H. pylori treatment
  • H. pylori positive by urea breath test, histology, or rapid urease test

Exclusion Criteria:

  • History of H. pylori eradication therapy
  • History of stomach operation
  • Other organ cancer within 5 years
  • Liver cirrhosis or Hepatic insufficiency
  • Renal insufficiency
  • Current treatment for serious medical condition which may hinder participation
  • Contraindication or allergy history for H. pylori treatment regimens
  • Mental incompetence to understand and sign informed consent
  • Incompatible conditions to be included into the trial by investigators' decision
  • Inability to provide an informed consent
  • History of treatment for peptic ulcer disease

Sites / Locations

  • National Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Standard triple therapy

Bismuth quadruple therapy

Arm Description

7 day-PPI based standard triple therapy

10 day-bismuth quadruple therapy

Outcomes

Primary Outcome Measures

H. pylori eradication rate

Secondary Outcome Measures

Complications of H. pylori treatment
Compliance to H. pylori treatment
H. pylori infection status at 1 year after H. pylori treatment
H. pylori reinfection rate
Factors associated with H. pylori reinfection

Full Information

First Posted
September 21, 2015
Last Updated
April 7, 2020
Sponsor
National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT02557932
Brief Title
Comparison of 7-day PPI-based Standard Triple Therapy and 10-day Bismuth Quadruple Therapy for H. Pylori Eradication
Official Title
Comparison of 7-day Proton Pump Inhibitor (PPI)-Clarithromycin Containing Triple Therapy and 10-day Bismuth Quadruple Therapy for Helicobacter Eradication as First-line Regimen: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
September 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In this randomized controlled trial, we investigate the effect of 10-day bismuth quadruple therapy in comparison with that of 7-day PPI-based standard triple as 1st line treatment for H. pylori.
Detailed Description
Current Helicobacter pylori management guidelines recommend proton-pump inhibitor (PPI)-Clarithromycin containing triple therapy as 1st line treatment. However, in Korea, eradication rates of PPI-Clarithromycin containing triple therapy have been decreased to less than 80% due to increased clarithromycin resistance. In areas of high clarithromycin resistance (resistance rate more than 15%), guidelines recommend bismuth quadruple therapy as a 1st line treatment for H. pylori eradication. Clarithromycin resistance rates reported from 15.7% to 42.1% in Korea, thus, bismuth quadruple therapy may be better 1st line treatment than PPI-Clarithromycin containing triple therapy. However, only one limited study was performed to compare effects of the both treatment regimens in Korea. Thus, studies evaluating the effect of 10-day bismuth quadruple therapy as the first line treatment for H. pylori infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection, Family History of Stomach Cancer
Keywords
PPI standard triple therapy, Bismuth quadruple therapy, Helicobacter

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
352 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard triple therapy
Arm Type
Active Comparator
Arm Description
7 day-PPI based standard triple therapy
Arm Title
Bismuth quadruple therapy
Arm Type
Active Comparator
Arm Description
10 day-bismuth quadruple therapy
Intervention Type
Drug
Intervention Name(s)
Standard triple therapy
Other Intervention Name(s)
7-day PPI-based standard triple therapy
Intervention Description
Lansoprazole 30mg, 2 times a day + Clarithromycin 500mg, 2 times a day + Amoxicillin 1000mg, 2 times a day for 7 days
Intervention Type
Drug
Intervention Name(s)
Bismuth quadruple therapy
Other Intervention Name(s)
10-day Bismuth quadruple therapy
Intervention Description
Lansoprazole 30mg, 2 times a day + Bismuth 300mg, 4 times a day + Tetracycline 500mg, 4 times a day + Metronidazole 500mg, 3 times a day for 10 days
Primary Outcome Measure Information:
Title
H. pylori eradication rate
Time Frame
8 weeks after H. pylori treatment
Secondary Outcome Measure Information:
Title
Complications of H. pylori treatment
Time Frame
1 month after H. pylori treatment
Title
Compliance to H. pylori treatment
Time Frame
1 month
Title
H. pylori infection status at 1 year after H. pylori treatment
Time Frame
1 year after H. pylori treatment
Title
H. pylori reinfection rate
Time Frame
3 years after success of H. pylori eradication
Title
Factors associated with H. pylori reinfection
Time Frame
3 years after success of H. pylori treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men and women aged 18 or more including following conditions Family history of gastric cancer Post endoscopic resection status for early gastric cancer or adenoma Peptic ulcer disease (benign gastric ulcer and duodenal ulcer) Chronic gastritis Non-ulcer dyspepsia Healthy adults who want to receive H. pylori treatment H. pylori positive by urea breath test, histology, or rapid urease test Exclusion Criteria: History of H. pylori eradication therapy History of stomach operation Other organ cancer within 5 years Liver cirrhosis or Hepatic insufficiency Renal insufficiency Current treatment for serious medical condition which may hinder participation Contraindication or allergy history for H. pylori treatment regimens Mental incompetence to understand and sign informed consent Incompatible conditions to be included into the trial by investigators' decision Inability to provide an informed consent History of treatment for peptic ulcer disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Il Ju Choi, M.D., Ph.D.
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Goyang
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
33653284
Citation
Kim YI, Lee JY, Kim CG, Park B, Park JY, Choi IJ. Ten-day bismuth-containing quadruple therapy versus 7-day proton pump inhibitor-clarithromycin containing triple therapy as first-line empirical therapy for the Helicobacter pylori infection in Korea: a randomized open-label trial. BMC Gastroenterol. 2021 Mar 2;21(1):95. doi: 10.1186/s12876-021-01680-1.
Results Reference
derived

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Comparison of 7-day PPI-based Standard Triple Therapy and 10-day Bismuth Quadruple Therapy for H. Pylori Eradication

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