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Personalized Treatment for Refractory H Pylori Infection

Primary Purpose

Helicobacter Pylori Infection

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

rabeprazole+3 antibiotics

rabeprazole+bismuth+2 antibiotics

rabeprazole+amox+tetr+levo

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter pylori, third-line therapy, antibiotic susceptibility, Eradication

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

H pylori-infected adult patients with at least two previous failed eradication attempts will be enrolled in this study after giving informed consent.

positive results of both rapid urease test and histology,
a positive result of Urea breath test,
or a positive result of culture

Exclusion Criteria:

ingestion of antibiotics, bismuth, or proton-pump inhibitor within the prior 4 weeks,
patients with allergic history to the medications used,
patients with previous gastric surgery,
the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
pregnant women.

Sites / Locations

Kaohsiung Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

rabeprazole+3 antibiotics

rabeprazole+bismuth+2 antibiotics

rabeprazole+amox+tetr+levo

Arm Description

patients who have positive result of culture with equal to or more than three susceptible antibiotics are treated by non-bismuth quadruple therapy (rabeprazole 20 mg q.d.s. and three effective antibiotics) for 14 days

patients who have positive result of culture with one or two susceptible antibiotics are treated by bismuth-containing therapy (rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics) for 14 days

patients who have negative result of culture or whose culture data are unavailable will be treated by (rabeprazole 20 mg q.d.s, amoxicillin 500 mg q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days

Outcomes

Primary Outcome Measures

Number of Participants in Which H. Pylori Was Eradicated

To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test.

Secondary Outcome Measures

Full Information

NCT ID

NCT02547025

First Posted

September 8, 2015

Last Updated

March 18, 2021

Sponsor

Kaohsiung Veterans General Hospital.

Collaborators

Kaohsiung Medical University Chung-Ho Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02547025

Brief Title

Personalized Treatment for Refractory H Pylori Infection

Official Title

Personalized Treatment for Refractory H Pylori Infection

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 2013 (undefined)

Primary Completion Date

October 31, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kaohsiung Veterans General Hospital.

Collaborators

Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

In this study, the investigators develop a personalized treatment according to culture-guided antibiotics plus high-dose proton-pump inhibitor and bismuth to treat refractory H pylori infection.

Detailed Description

They are categorized into three groups: (1) patients who have positive result of culture with equal to or more than three susceptible antibiotics are treated by non-bismuth quadruple therapy (rabeprazole 20 mg q.d.s. and three effective antibiotics), (2) patients who have positive result of culture with one or two susceptible antibiotics are treated by bismuth-containing therapy (rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics), and (3) patients who have negative result of culture or whose culture data are unavailable will be treated by (rabeprazole 20 mg q.d.s, amoxicillin 500 mg q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Helicobacter Pylori Infection

Keywords

Helicobacter pylori, third-line therapy, antibiotic susceptibility, Eradication

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

rabeprazole+3 antibiotics

Arm Type

Experimental

Arm Description

Arm Title

rabeprazole+bismuth+2 antibiotics

Arm Type

Experimental

Arm Description

Arm Title

rabeprazole+amox+tetr+levo

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

rabeprazole+3 antibiotics

Other Intervention Name(s)

rabeprazole 20 mg, amoxicillin 1g, clarithromycin 500mg, metrondazole 250mg, tetracycline 500mg, levofloxacin 500mg

Intervention Description

(rabeprazole 20 mg q.d.s. and three effective antibiotics) for 14 days.

Intervention Type

Drug

Intervention Name(s)

rabeprazole+bismuth+2 antibiotics

Other Intervention Name(s)

rabeprazole 20 mg, bismuth subcitrate 120 mg, amoxicillin 1g, clarithromycin 500mg, metrondazole 250mg, tetracycline 500mg, levofloxacin 500mg

Intervention Description

(rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics) for 14 days.

Intervention Type

Drug

Intervention Name(s)

rabeprazole+amox+tetr+levo

Other Intervention Name(s)

rabeprazole 20 mg, bismuth subcitrate 120 mg, tetracycline 500mg, levofloxacin 500mg

Intervention Description

(rabeprazole 20 mg q.d.s, amoxicillin 500 mg q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days.

Primary Outcome Measure Information:

Title

Number of Participants in Which H. Pylori Was Eradicated

Description

To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test.

Time Frame

eight weeks after the end of anti-H pylori therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: H pylori-infected adult patients with at least two previous failed eradication attempts will be enrolled in this study after giving informed consent. positive results of both rapid urease test and histology, a positive result of Urea breath test, or a positive result of culture Exclusion Criteria: ingestion of antibiotics, bismuth, or proton-pump inhibitor within the prior 4 weeks, patients with allergic history to the medications used, patients with previous gastric surgery, the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia), pregnant women.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ping-I Hsu, Bachelor

Phone

+886-7-342-2121

Ext

8078

williamhsup@yahoo.com.tw

First Name & Middle Initial & Last Name or Official Title & Degree

Feng-woei Tsay, Bachelor

Phone

+886-7-342-2121

Ext

8233

fwchaie@vghks.gov.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ping-I Hsu, Bachelor

Organizational Affiliation

Kaohsiung Veterans General Hospital.

Official's Role

Study Chair

Facility Information:

Facility Name

Kaohsiung Veterans General Hospital

City

Kaohsiung

ZIP/Postal Code

813

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ping I Hsu, MD

Phone

886-7346-8237

williamhsup@yahoo.com.tw

First Name & Middle Initial & Last Name & Degree

Feng-Woei Chiae, Bachelor

Phone

+886-7-342-2121

Ext

2074

fwchiae@vghks.gov.tw

First Name & Middle Initial & Last Name & Degree

Ping I Hsu, MD

12. IPD Sharing Statement

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Personalized Treatment for Refractory H Pylori Infection

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