NCT02349685

Brief Summary

As increasing the antibiotics resistance, the effectiveness of traditional Helicobacter pylori (H. pylori) therapies has been declined coincidently. In this study, the investigators evaluated the efficacy of H. pylori eradication between a personalized therapy for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the traditional 2nd rescue regimens, and the investigators analyzed the prevalence of the antibiotic resistance after 1st eradication of H. pylori in the tailored therapy group.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
219

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

October 4, 2016

Completed
Last Updated

October 4, 2016

Status Verified

August 1, 2016

Enrollment Period

4.4 years

First QC Date

January 25, 2015

Results QC Date

April 26, 2016

Last Update Submit

August 9, 2016

Conditions

Helicobacter Infection

Keywords

Helicobacter pyloriPersonalized therapyantimicrobial susceptibilityrescue therapyculture

Outcome Measures

Primary Outcomes (1)

  • Number of Participants in Each Arm/Group With Successful H. Pylori Eradication

    the efficacy of H. pylori eradication between a personalized therapy for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the traditional 2nd rescue regimens. The eradication rate was evaluated by intention to treat (ITT)

    6 weeks after completion of eradication

Secondary Outcomes (1)

  • Number of Participants in Each Arm/Group With Successful H. Pylori Eradication

    6 weeks after completion of eradication

Study Arms (3)

14 day bismuth based quadruple therapy (PBMT) group

EXPERIMENTAL

Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d

Drug: 14 day PBMT group

14 day Moxifloxacin containing triple therapy (MEA) group

EXPERIMENTAL

PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.

Drug: 14 day MEA group

14 day tailored therapy group

ACTIVE COMPARATOR

based on H. pylori culture and antimicrobial sensitivity, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.

Procedure: H. pylori culture and antimicrobial susceptibility test

Interventions

H. pylori culture and antimicrobial susceptibility testPROCEDURE

Antral and body biopsy specimens were evaluated separately. Organisms were identified as H. pylori by Gram staining, colony morphology, and positive oxidase, catalase, and urease reactions. Minimum inhibitory concentrations (MICs) were determined by the agar dilution method. Amoxicillin (Sigma Chemical Co., St. Louis, Mo.), clarithromycin (Abbott Laboratories, Abbott Park, Ill.), metronidazole (Sigma), tetracycline (Sigma) and moxifloxacin (Sigma) for the H. pylori isolates were examined by use of the serial twofold agar dilution method and the reference of susceptibility testing was according to the recommendations of the Clinical and Laboratory Standards Institute \[amoxicillin (AMC), MIC ≥ 0.5 μg / ml; clarithromycin (CLA), MIC \> 1.0 μ g / ml; metronidazole (MET), MIC \> 8 μ g / ml; tetracycline (TC), MIC \> 4 μ g / ml; and moxifloxacin (MOX), MIC \> 1 μ g / ml).

14 day tailored therapy group
14 day PBMT groupDRUG

Rescue therapy using 14 day PBMT regimen \[Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d\]

14 day bismuth based quadruple therapy (PBMT) group
14 day MEA groupDRUG

Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)

14 day Moxifloxacin containing triple therapy (MEA) group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients who proved a failure of 1st eradication of H. pylori with Proton pump inhibitor based triple therapy (PPI bid + amoxacillin 1g b.i.d + Clarithromycin 500 mg b.i.d) or sequential therapy (initial 5-day therapy with a combination of PPI b.i.d and amoxicillin 1g b.i.d, followed by 5 days of PPI b.i.d., clarithromycin 500mg b.i.d., and metronidazole 500mg t.i.d) following three methods
  • positive rapid urease test (CLOtest)
  • histologic evidence of H. pylori by modified Giemsa staining
  • positive 13C-Urea breath test
  • Male and female Korean Adult (Aged ≥ 18 years)

You may not qualify if:

  • Patients who received two or more eradication therapy for H. pylori infection
  • H. pylori eradication failure because of poor compliance
  • the administration of antibiotics or the consumption of bismuth salts within 4 weeks or the administration of a proton pump inhibitor (PPI) within 2 weeks
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kwon YH, Kim N, Lee JY, Choi YJ, Yoon K, Nam RH, Suh JH, Lee JW, Lee DH. Comparison of the efficacy of culture-based tailored therapy for Helicobacter pylori eradication with that of the traditional second-line rescue therapy in Korean patients: a prospective single tertiary center study. Scand J Gastroenterol. 2016 Mar;51(3):270-6. doi: 10.3109/00365521.2015.1095352. Epub 2015 Oct 9.

    PMID: 26452405DERIVED

MeSH Terms

Conditions

Helicobacter Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Limitations and Caveats

Early termination leading to small number of subjects analyzed

Results Point of Contact

Title
Nayoung Kim
Organization
SeoulNUBH
nayoungkim49@empas.com
+ 82-31-787-7008

Study Officials

  • Nayoung Kim, M.D., Ph. D

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 25, 2015

First Posted

January 29, 2015

Study Start

January 1, 2010

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

October 4, 2016

Results First Posted

October 4, 2016

Record last verified: 2016-08