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Pilot Study of a 14-day Modified Sequential Therapy for Helicobacter Pylori Infection

Primary Purpose

Helicobacter Pylori Infection

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
rabeprazole, amoxicillin, tetracycline, furazolidone (only for the first 7 days), colloidal bismuth pectin (for the second 7 days)
Sponsored by
Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Sequential Therapy, Rescue Treatment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 18-70 with persistent H. pylori infection.
  • Patients failed at least three different standard eradication therapies before. Previous standard eradication therapy was defined as a 10-day or 14-day quadruple regimen designed according to Maastricht V report.

Exclusion Criteria:

  • Patients unable or unwilling to receive gastroscopy.
  • Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks.
  • Patients with gastorectomy, acute GI bleeding and advanced gastric cancer.
  • History of allergy to any of the drugs used in the study.
  • Severe concomitant cardiovascular, respiratory, or endocrine diseases, clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk.
  • Currently pregnant or lactating.
  • Severe neurologic or psychiatric disorders.
  • Alcohol abuse or drug addiction.
  • Patients with compliance lower than 90% in any previous treatment are not included.
  • Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Sites / Locations

  • Xiuli Zuo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

14-day modified sequential therapy

Arm Description

All the participants will go through a gastroscopy. Biopsy specimens will be taken for histologic assessment and rapid urease test. Two additional biopsy samples will be obtained from the antrum and body for bacterial culture and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment. Then, patients will receive a 14-day modified sequential therapy for the Helicobacter pylori eradication irrespective of antimicrobial susceptibility test results. The regimen contains rabeprazole, amoxicillin, tetracycline and furazolidone for the first 7 days, followed by rabeprazole，amoxicillin, tetracycline and colloidal bismuth pectin for the second 7 days. Drugs: 1. rabeprazole 10mg bid for 14 days, 2. amoxicillin 1000mg bid for 14 days, 3. tetracycline 500mg qid for 14 days, 4. furazolidone 100mg tid for the firs 7 days, 5. colloidal bismuth pectin 200mg bid for the second 7 days.

Outcomes

Primary Outcome Measures

Eradication rates
Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infection. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.

Secondary Outcome Measures

The rate of adverse events happening
Common adverse events will be measured using a 8-point Likert scale, and patients rate their symptoms from 0 (none) to 8 (severe) during the treatment process.
The rate of improving dyspepsia symptoms after Helicobacter pylori eradication.
Dyspepsia symptoms will also be measured using a 8-point Likert scale
The rate of good compliance
Patients taken over 90% of drugs are considered to have a good compliance.

Full Information

First Posted
July 31, 2018
Last Updated
March 6, 2019
Sponsor
Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT03616405
Brief Title
Pilot Study of a 14-day Modified Sequential Therapy for Helicobacter Pylori Infection
Official Title
Efficacy and Safety of a 14-day Modified Sequential Therapy for Refractory Helicobacter Pylori Infection: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Anticipated)
Primary Completion Date
November 30, 2019 (Anticipated)
Study Completion Date
April 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess efficacy of a 14-day sequential therapy for the rescue treatment of refractory Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates.
Detailed Description
Half of the world's population is infected with Helicobacter pylori. Strong evidence supports that H.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. However, eradication rates of first-line therapy decreased over years due to the rapidly emerging antibiotic resistance of H. pylori worldwide. An ideal rescue therapeutic regimen to cure refractory H.pylori infection is currently warranted. Traditional sequential therapy failed to achieve an ideal eradication rates (over>95%) as a third line treatment in the region with high antibiotic resistance. The investigator's study aims to evaluate the efficacy 14-day modified sequential therapy in the patients with two or more treatment failure, and whether the adverse effects of this new modified sequential therapy are tolerable.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
Sequential Therapy, Rescue Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
14-day modified sequential therapy
Arm Type
Experimental
Arm Description
All the participants will go through a gastroscopy. Biopsy specimens will be taken for histologic assessment and rapid urease test. Two additional biopsy samples will be obtained from the antrum and body for bacterial culture and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment. Then, patients will receive a 14-day modified sequential therapy for the Helicobacter pylori eradication irrespective of antimicrobial susceptibility test results. The regimen contains rabeprazole, amoxicillin, tetracycline and furazolidone for the first 7 days, followed by rabeprazole，amoxicillin, tetracycline and colloidal bismuth pectin for the second 7 days. Drugs: 1. rabeprazole 10mg bid for 14 days, 2. amoxicillin 1000mg bid for 14 days, 3. tetracycline 500mg qid for 14 days, 4. furazolidone 100mg tid for the firs 7 days, 5. colloidal bismuth pectin 200mg bid for the second 7 days.
Intervention Type
Drug
Intervention Name(s)
rabeprazole, amoxicillin, tetracycline, furazolidone (only for the first 7 days), colloidal bismuth pectin (for the second 7 days)
Intervention Description
Patients will go through a gastroscopy and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment. Then, patients will receive a 14-day modified sequential therapy for the Helicobacter pylori eradication. The regimen contains rabeprazole, amoxicillin, tetracycline and furazolidone for the first 7 days, followed by rabeprazole，amoxicillin, tetracycline and colloidal bismuth pectin for the second 7 days.
Primary Outcome Measure Information:
Title
Eradication rates
Description
Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infection. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The rate of adverse events happening
Description
Common adverse events will be measured using a 8-point Likert scale, and patients rate their symptoms from 0 (none) to 8 (severe) during the treatment process.
Time Frame
6 months
Title
The rate of improving dyspepsia symptoms after Helicobacter pylori eradication.
Description
Dyspepsia symptoms will also be measured using a 8-point Likert scale
Time Frame
6 months
Title
The rate of good compliance
Description
Patients taken over 90% of drugs are considered to have a good compliance.
Time Frame
6 months

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 18-70 with persistent H. pylori infection. Patients failed at least three different standard eradication therapies before. Previous standard eradication therapy was defined as a 10-day or 14-day quadruple regimen designed according to Maastricht V report. Exclusion Criteria: Patients unable or unwilling to receive gastroscopy. Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks. Patients with gastorectomy, acute GI bleeding and advanced gastric cancer. History of allergy to any of the drugs used in the study. Severe concomitant cardiovascular, respiratory, or endocrine diseases, clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk. Currently pregnant or lactating. Severe neurologic or psychiatric disorders. Alcohol abuse or drug addiction. Patients with compliance lower than 90% in any previous treatment are not included. Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiuli Zuo, MD,PhD
Phone
15588818685
Email
zuoxiuli@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiuli Zuo, MD,PhD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiuli Zuo, MD,PhD
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiuli Zuo
City
Jinan
State/Province
Shandong
Country
China

12. IPD Sharing Statement

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Pilot Study of a 14-day Modified Sequential Therapy for Helicobacter Pylori Infection

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